SOEHENDRA LITHOTRIPSY SET
FDA 510(k) clearance K902170 · decided 1990-07-25
Clearance details
- K-number
- K902170
- Device name
- SOEHENDRA LITHOTRIPSY SET
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-14
- Decision date
- 1990-07-25
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LQC
- Device class
- 2
- Regulation number
- 876.4500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winston-Salem, NC, 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 |
|---|---|---|
| TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 (K040447) | Boston Scientific Corp | 2004-03-12 |
| WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR (K011178) | Wilson-Cook Medical, Inc. | 2001-05-04 |
| A LITHOTRIPTER-COMPATIBLE BASKET (K964937) | Boston Scientific Corp | 1997-01-24 |
| GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS (K942544) | Medi-Globe Corp. | 1994-11-22 |
| MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR (K943191) | Boston Scientific Corp | 1994-08-29 |
| LAPAROLITH (K905552) | Baxter Healthcare Corp | 1991-12-17 |
| SPOON FORCEPS, 11MM (K911364) | Northgate Technologies, Inc. | 1991-10-23 |
| LAPAROSCOPIC BASKET FLEXIBLE AND RIGID (K911477) | United States Endoscopy Group, Inc. | 1991-08-14 |
| BML SERIES (K903529) | Olympus Corp. | 1991-01-23 |
| ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER (K860863) | George Percy Mcgown | 1986-05-15 |
Recalls involving this device
No recalls on record reference this clearance.