Mini Endoscope, Gastroenterology-urology
Gastroenterology, Urology · 21 CFR 876.1500
To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Recent MDR events
28 adverse event reports on file
- EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPESep 20, 2022MalfunctionShirakawa Olympus Co., Ltd.3002808148-2022-02231
- SPYGLASS DIRECT VISUALIZATION SYSTEMOct 5, 2017MalfunctionBoston Scientific - Marlborough3005099803-2017-02914
- SPYGLASS DIRECT VISUALIZATION SYSTEMJan 28, 2016MalfunctionBoston Scientific - Marlborough3005099803-2016-00162
- SPYGLASS DIRECT VISUALIZATION SYSTEMSep 11, 2015DeathBoston Scientific - Marlborough3005099803-2015-02519
- SPYGLASS DIRECT VISUALIZATION SYSTEMAug 12, 2014InjuryBoston Scientific - Marlborough3005099803-2014-02821
- SPYGLASS DIRECT VISUALIZATION SYSTEMJun 16, 2014MalfunctionBoston Scientific - Marlborough3005099803-2014-02236
- SPYGLASS DIRECT VISUALIZATION SYSTEMJul 24, 2013InjuryBoston Scientific - Marlborough3005099803-2013-07518
- SPYGLASS DIRECT VISUALIZATION SYSTEMMay 17, 2013MalfunctionBoston Scientific - Marlborough3005099803-2013-03981
- SPYGLASS DIRECT VISUALIZATION SYSTEMMay 17, 2013InjuryBoston Scientific - Marlborough3005099803-2013-03977
- SPYGLASS DIRECT VISUALIZATION SYSTEMMar 28, 2012MalfunctionBoston Scientific - Marlborough3005099803-2012-01141
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
12 clearances for this product code
- C-Link Micro Imaging, Inc.Jan 12, 2010
K092739 · MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE
- Lumenis, Inc.Sep 30, 2009
K091962 · POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
- Boston Scientific CorpFeb 4, 2009
K090170 · SPYSCOPE ACCESS AND DELIVERY CATHETER
- Boston Scientific CorpAug 24, 2005
K052194 · SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
- Boston Scientific CorpMar 4, 2005
K050403 · SPYGLASS DIRECT VISULATION PROBE
- Five Star Medical, Inc.Sep 8, 1997
K963354 · 5 STAR MEDICAL ENDOSCOPE
- Ovamed Corp.Mar 22, 1995
K943593 · SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM
- Candela Laser Corp.Jun 17, 1994
K941230 · MINI-UB ENDOSCOPES