REFLEX SDD SURGICAL STAPLER
FDA 510(k) clearance K933508 · decided 1993-11-23
Clearance details
- K-number
- K933508
- Device name
- REFLEX SDD SURGICAL STAPLER
- Applicant
- Richard-Allan Medical
- Decision
- Substantially Equivalent
- Date received
- 1993-07-20
- Decision date
- 1993-11-23
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- GEF
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Richland, MI, 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 |
|---|---|---|
| MICROAIRE MODEL 2600 (K915670) | Microaire | 1992-03-18 |
| V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (K854568) | American V. Mueller | 1985-12-02 |
| 3M FRASCIA STAPLING SYSTEM (K823888) | 3M Company | 1983-01-09 |
Recalls involving this device
No recalls on record reference this clearance.