Trocar, Gastro-urology
Gastroenterology, Urology · 21 CFR 876.5090
Recent MDR events
38 adverse event reports on file
- TROCAR SLEEVE STRAI. CAP 5.8MM WL 62MMApr 4, 2025DeathRichard Wolf Gmbh9611102-2025-00018
- 3.2MM PELLET INSERTION TRAY #2 - STERILE / LATEX FREESep 28, 2024Injury75 Arkay Drive2433012-2024-00001
- NAOct 17, 2022MalfunctionRichard Wolf Gmbh9611102-2022-00055
- SEALING UNIT F/10/12MM TROCARS W.REDUCERMay 11, 2022InjuryAesculap Ag2916714-2022-00050
- SEALING UNIT F/10/12MM TROCARS W.REDUCERMay 11, 2022InjuryAesculap Ag9610612-2022-00120
- COOK BRAND TRANSEPTAL NEEDLEApr 16, 2019InjuryCook, Inc.MW5085939
- DISPOSABLE TWO-PART TROCAR NEEDLEDec 19, 2018MalfunctionCook Inc1820334-2018-03684
- STRAIGHT TROCAR SLEEVEOct 9, 2017InjuryRichard Wolf Germany (rwgmbh)1418479-2017-00027
- DISP.TROCAR THRD.W.DILATING PIN 12/110MMApr 21, 2016MalfunctionAesculap Ag2916714-2016-00309
- EB040, OPEN FUSION DEVICE, 6/BXMar 20, 2015MalfunctionApplied Medical2027111-2015-00114
Event type breakdown
Recalls
25 recall events for this product code
- Busse Hospital Disposables, Inc.TerminatedUnknown
3.2MM Pellet Insertion Tray
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1179-2022 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
"3.2MM Pellet Insertion Tray with Medium Gloves"
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1180-2022 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
SS 3.5Mm Pellet Insertion Tray with large Gloves
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1181-2022 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
SS 3.5Mm Pellet Insertion Tray with large Gloves
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1182-2022 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
SS 3.5MM Pellet Insertion Tray with Medium Gloves
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1183-2022 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
SS 3.5MM Pellet Insertion Tray with Medium Gloves
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1184-2022 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
4.5MM Pellet Insertion Tray with Large Gloves
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1185-2022 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
4.5MM Pellet Insertion Tray with Medium Gloves
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1186-2022 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
SS 4.5MM Pellet Insertion Tray with Large Gloves
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1187-2022 · View FDA record ↗ - Busse Hospital Disposables, Inc.TerminatedUnknown
SS 4.5MM Pellet Insertion Tray with Large Gloves
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Z-1188-2022 · View FDA record ↗
Registered firms
38 firms currently registered for this product code
Endomed, Llc
Orlando, FL, US
Trokamed Gmbh
GEISINGEN Baden-Wurttemberg, DE
Bak Kohler Medical Kg
NEUHAUSEN OB ECK-Schwandorf Baden-Wurttemberg, DE
Platinum Focus Group Ltd.
London London, City of, GB
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Richard Wolf Gmbh
KNITTLINGEN Baden-Wurttemberg, DE
Biorad Medisys Pvt. Ltd.
Pune Maharashtra, IN
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Allwin Medical Devices, Inc.
ANAHEIM, CA, US
Busse Hospital Disposables
HAUPPAUGE, NY, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Sterigenics U.s., Llc
Atlanta, GA, US
Cook Incorporated
Bloomington, IN, US
Covidien
- Santo Domingo, DO
Integra Lifesciences Corporation
Princeton, NJ, US
Cook Incorporated
Spencer, IN, US
Hangzhou Endo Medical Instrument Co.,ltd
hangzhou Zhejiang, CN
Pharmco Medical Bv
ROTTERDAM Zuid-Holland, NL
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Allwin Medical Devices Pvt. Ltd.
Surat Gujarat, IN
Meister Surgical Instruments
Sialkot Punjab, PK
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Surgicrafts
Sialkot Punjab, PK
B. Ali Impex
SIALKOT, Punjab, PK
510(k) clearances
9 clearances for this product code
- Gibbons Surgical Corp.Aug 9, 2001
K012198 · GIBBONS STERILE TROCAR KITS
- Endoscopic Concepts, Inc.Apr 1, 1998
K980804 · SABRE BT BLUNT0TIP SURGICAL TROCAR
- Gabris Surgical Corp.Oct 11, 1994
K944640 · LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT
- Gabris Surgical Corp.Sep 13, 1994
K944104 · GABRIS LAPAROSCOPIC SURGICAL KITS
- United States Surgical, A Division of Tyco HealthcAug 22, 1994
K942885 · AUTO SUTURE MODIFIED GRIP
- Aesculap, Inc.Dec 23, 1993
K934724 · AESCULAP TROCAR INSTRUMENT SET
- L.A.S.E.R., Inc.Feb 21, 1991
K904638 · TROCAR DISPOSABLE
- United States Surgical, A Division of Tyco HealthcApr 4, 1990
K900123 · AUTO SUTURE SURGIPORT SPIRAL SLEEVE