Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
Obstetrics/Gynecology · 21 CFR 884.4150
Recent MDR events
268 adverse event reports on file
- CUTTING LOOP, BIPOLAR, 26 FR.Jul 13, 2026InjuryKarl Storz Se & Co. Kg2020550-2025-01675
- CUTTING LOOP, BIPOLAR, 26 FR.Jun 1, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01255
- 26040GP1May 7, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01034
- VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTINGMay 7, 2026InjuryOlympus Winter & Ibe Gmbh9610773-2026-03611
- CUTTING ELECTRODE, BIPOLAR, 26 FR.Apr 7, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-00772
- ELECTRODE, BIPOLARMar 30, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-00674
- ELECTRODE, BIPOLARMar 11, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-00523
- ELECTRODE, BIPOLARMar 11, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-00521
- ELECTRODE, BIPOLARMar 10, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-00522
- ELECTRODE, BIPOLARMar 10, 2026InjuryKarl Storz Se & Co. Kg9610617-2026-00521
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
36 firms currently registered for this product code
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Elmed, Inc.
Glendale Heights, IL, US
Arvato Se
Hamburg, DE
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Gyrus Medical Ltd.
CARDIFF Wales, GB
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Olympus Winter & Ibe Gmbh
HAMBURG, DE
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Primo Medical Group, Inc
W Bridgewater, MA, US
Lynx Medical Nj
Franklin, NJ, US
Millennium Surgical Corp
Schaumburg, IL, US
Synergy Health Sterilisation Uk Ltd
Berkshire Reading, GB
Instrumed International Inc Dba Avalign German Specialty Instruments
SCHAUMBURG, IL, US
Richard Wolf Medical Instruments Corp.
VERNON HILLS, IL, US
Grace Manufacturing Inc
Russellville, AR, US
Lina Medical Ag
Root D4 Luzern, CH
Gyrus Acmi, Inc.
Westborough, MA, US
Surgical Direct, Inc.
Orange City, FL, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Lina Medical Polska Sp. Z O.o
Tarnowo Podgorne Wielkopolskie, PL
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
510(k) clearances
16 clearances for this product code
- Olympus Winter & Ibe GmbHNov 21, 2014
K142525 · PK Lap Loop
- Lina Medical ApsJul 24, 2013
K130305 · LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
- KARL STORZ Endoscopy-America, Inc.Jun 26, 2013
K122983 · KSEA BIPOLAR ELECTRODE
- Gyrus Acmi, Inc.Dec 5, 2012
K122605 · PKS BILL
- Mectra Labs, Inc.Jun 29, 2012
K113080 · TUBALGATOR
- ETHICON, Inc.Dec 2, 2011
K111751 · VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
- Gyrus Acmi, Inc.Sep 1, 2011
K111059 · GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
- Richard Wolf Medical Instruments Corp.Apr 16, 1999
K990147 · BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771