Endoscopic Grasping/cutting Instrument, Non-powered, Exempt
Gastroenterology, Urology · 21 CFR 876.1500
This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Recent MDR events
355 adverse event reports on file
- SpyGlass? Retrieval SnareJul 30, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03097
- CentraJul 27, 2026InjuryUs Endoscopy1528319-2026-00089
- CENTRAJul 16, 2026MalfunctionUs Endoscopy1528319-2026-00084
- CENTRAJul 14, 2026MalfunctionUnited States Endoscopy Group, Inc.1528319-2026-00081
- SINGLE USE LOOP CUTTER FS-410Jul 10, 2026InjuryAomori Olympus Co., Ltd.9614641-2026-00743
- CAPTURA PRO BIOPSY FORCEPSJul 10, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00341
- CENTRAJul 2, 2026MalfunctionUs Endoscopy1528319-2026-00077
- CENTRAJun 26, 2026MalfunctionUs Endoscopy1528319-2026-00075
- CENTRAJun 18, 2026MalfunctionUs Endoscopy1528319-2026-00070
- SPYGLASS RETRIEVAL BASKETMay 29, 2026InjuryBoston Scientific Corporation3005099803-2026-02213
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
59 firms currently registered for this product code
Cook Medical Llc
Bloomington, IN, US
Marflow Ag
ISLIKON Thurgau, CH
Uroviu Corporation
Los Altos, CA, US
Eternal (shanghai) Medical Technology Co., Ltd.
Shanghai, CN
Seplou (zhuhai) Co.,ltd.
Zhuhai Guangdong, CN
Ovesco Endoscopy Usa
Cary, NC, US
Changzhou Jiuhong Medical Instrument Co., Ltd.
CHANGZHOU Jiangsu, CN
Micro-tech (nanjing) Co., Ltd.
Nanjing Jiangsu, CN
Zhuji Pengtian Medical Instrument Co.,ltd.
Zhuji Zhejiang, CN
Primed Instruments, Inc.
MISSISSAUGA Ontario, CA
Olympus Vietnam Co. Ltd.
Dong Nai City, VN
Beijing Zksk Technology Co., Ltd.
beijing, CN
Wilson-cook Medical Inc.
Winston Salem, NC, US
Steriservice Sp. Z O.o.
Czestochowa Slaskie, PL
Biorad Medisys Pvt. Ltd.
Pune Maharashtra, IN
Ags Medtech (thailand) Co., Ltd.
Pluak Daeng District Rayong, TH
Boston Scientific Limited
GALWAY, IE
Jiangsu Kangjin Medical Instrument Co.,ltd.
Changzhou Jiangsu, CN
Jiangsu Vedkang Medical Science And Technology Co.,ltd.
Changzhou Jiangsu, CN
Micro-tech (nanjing) Co., Ltd.
NAN JING Jiangsu, CN
Primo Medical Group, Inc
STOUGHTON, MA, US
Lina Medical Ag
Root D4 Luzern, CH
Jiangsu Power-endo Medical Technology Co., Ltd.
Changzhou Jiangsu, CN
Zhuhai Pusen Medical Technology Co., Ltd.
Zhuhai Guangdong, CN
Anrei Medical (hz) Co., Ltd.
HANGZHOU Zhejiang, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.