DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE— 510(k) K962676
Substantially EquivalentUnited States Endoscopy Group, Inc.
FDA 510(k) clearance K962676 for DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE, Substantially Equivalent on 1996-10-04. Applicant: United States Endoscopy Group, Inc.. Device class: 2.
Clearance details
- Applicant
- United States Endoscopy Group, Inc.
- Product code
- Code FGO
- Device class
- Class 2
- Regulation
- 21 CFR 876.4680
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Recent devices under product code FGO
view allMore clearances from United States Endoscopy Group, Inc.
view allRecalls naming K962676
K-number listed on FDA's recall record- Z-1453-2015 — Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
- Z-0006-2013 — Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962676.
Data sourced from openFDA. This site is unofficial and independent of the FDA.