Surgical Instruments, G-u, Manual (and Accessories)
Gastroenterology, Urology · 21 CFR 876.4730
Recent MDR events
37 adverse event reports on file
- RIGID WINDOWED GRASPING FORCEPS, 3MM, 37CMNov 25, 2025InjuryGyrus Acmi, Inc.3011050570-2025-01370
- BROOKS DILATOR SETApr 16, 2025MalfunctionColoplast A/s2125050-2025-00614
- BROOKS DILATOR SETFeb 20, 2025InjuryColoplast A/s2125050-2025-00266
- GOMCO STYLE CIRCUMCISION CLAMP, INFANT, 1.45CMNov 20, 2024MalfunctionElmed Incorporated20733354
- BROOKS DILATOR SETJul 30, 2024MalfunctionColoplast A/s2125050-2024-01161
- MONARCH HSG TRAY PACKAug 11, 2023MalfunctionMonarch Medical Products, Inc.17509005
- RIGID WINDOWED GRASPING FORCEPS, 3MM, 37CMAug 9, 2023InjuryUnkMW5122863
- RIGID WINDOWED GRASPING FORCEPS, 3MM, 37CMJun 2, 2023InjuryGyrus Acmi, Inc.3011050570-2023-00053
- BROOKS DILATORMay 23, 2023InjuryColoplast A/s2125050-2023-00609
- MILLENNIUM PRATT RECTAL PROBE 73/4 SILVERFeb 6, 2023InjuryMillennium / Instrumed International Inc., Dba Avalign German Specialty Instruments.MW5114735
Event type breakdown
Recalls
6 recall events for this product code
- Aesculap Implant Systems LLCCompletedUnknown
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Z-1481-2022 · View FDA record ↗ - Aesculap Implant Systems LLCCompletedUnknown
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Z-1482-2022 · View FDA record ↗ - Uromedica Inc.TerminatedUnknown
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
Z-1808-2020 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages.
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Z-2310-2017 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages.
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Z-2311-2017 · View FDA record ↗ - Cook Inc.TerminatedUnknown
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages.
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Z-2312-2017 · View FDA record ↗
Registered firms
121 firms currently registered for this product code
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Sterigenics U.s., Llc
Charlotte, NC, US
Novo Surgical, Inc.
Westmont, IL, US
Millennium Surgical Corp
Schaumburg, IL, US
Itm Industria De Tecnologias Medicas Ltda
CANOAS Rio Grande do Sul, BR
Rigicon, Inc.
Ronkonkoma, NY, US
Apothecaries Sundries Mfg Pvt Ltd
GURUGRAM Haryana, IN
Cislak Manufacturing, Inc.
NILES, IL, US
Arvato Se
Hamburg, DE
Sklar Corporation - Warehouse
Salisbury, MD, US
Lighthouse For The Blind
Saint Louis, MO, US
Dongguan Shin Yi Healthcare Products Factory
DONG GUAN CITY Guangdong, CN
Addn Solutions Gmbh & Co. Kg
Wurmlingen Baden-Wurttemberg, DE
Trokamed Gmbh
GEISINGEN Baden-Wurttemberg, DE
Pro-med Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Dausch Medizintechnik Gmbh
WURMLINGEN Baden-Wurttemberg, DE
Surgiscape
Sialkot Punjab, PK
Accurate Surgical & Scientific Instruments Corp.
WESTBURY, NY, US
Avilign Medical
Sialkot Punjab, PK
Teleflex Llc (nadc)
Olive Branch, MS, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Lone Star Medical Products
Stafford, TX, US
Grace Manufacturing Inc
Russellville, AR, US
510(k) clearances
44 clearances for this product code
- Agency For Medical Innovations GmbHDec 7, 2018
K182664 · FiXcision
- Applied Medical ResourcesJan 31, 1995
K950267 · URETHRAL SUTURE GUIDE
- Femcare , Ltd.Mar 2, 1994
K932465 · LI VASECTOMY
- Cook Urological, Inc.Jul 2, 1993
K921546 · VASOVASOSTOMY SET
- Vesitec Medical, Inc.May 12, 1993
K931181 · VESITEC SUTURE PASSER
- North American Medical, Inc.Oct 5, 1992
K921304 · DDV LIGATOR
- Pilling Co.Sep 23, 1992
K922971 · NO-SCALPEL VASCETOMY INSTRUMENTS
- Eimark Labs, Inc.Sep 14, 1992
K921228 · BENDEREV PROTECT-A-PASS NEEDLE