DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
FDA 510(k) clearance K962676 · decided 1996-10-04
Clearance details
- K-number
- K962676
- Device name
- DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
- Applicant
- United States Endoscopy Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-09
- Decision date
- 1996-10-04
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- FGO
- Device class
- 2
- Regulation number
- 876.4680
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (K001563) | Scion Cardiovascular, Inc. | 2000-11-22 |
| STONE DISLODGER, BASKET (K970121) | Boston Scientific Corp | 1997-04-02 |
| RETRIEVAL SNARE (K963750) | Boston Scientific Corp | 1996-11-22 |
| STONE DISLODGER, BASKET (K951309) | Boston Scientific Corp | 1995-05-17 |
| GRASPING FORCEPS (K933261) | Surgitek | 1994-01-11 |
| GRASPING FORCEPS OR RETRIEVAL FORCEPS (K934598) | Annex Medical, Inc. | 1994-01-07 |
| INTRAVENOUS CATHETERS MODIFICATIONS (K921295) | Critikon Company, LLC | 1993-05-17 |
| GRASPING FORCEPS (K922542) | Surgitek | 1992-08-19 |
| METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE (K914112) | Annex Medical, Inc. | 1992-02-28 |
| METAL URETERAL BASKET STONE DISLODGER, HELICAL (K914111) | Annex Medical, Inc. | 1992-02-28 |
| GRASPING FORCEPS (K914110) | Annex Medical, Inc. | 1992-02-28 |
| CN GAURD, STERILE LATEX SURGICAL GLOVES (K896322) | C.N. Technocrats | 1990-07-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue recall (Z-1453-2015) | US Endoscopy Group Inc | 2015-04-16 |
| Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve recall (Z-0006-2013) | US Endoscopy Group Inc | 2012-10-03 |