V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP
FDA 510(k) clearance K854568 · decided 1985-12-02
Clearance details
- K-number
- K854568
- Device name
- V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP
- Applicant
- American V. Mueller
- Decision
- Substantially Equivalent
- Date received
- 1985-11-14
- Decision date
- 1985-12-02
- Days to decision
- 18 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
- Chicago, IL, 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 |
|---|---|---|
| REFLEX SDD SURGICAL STAPLER (K933508) | Richard-Allan Medical | 1993-11-23 |
| MICROAIRE MODEL 2600 (K915670) | Microaire | 1992-03-18 |
| 3M FRASCIA STAPLING SYSTEM (K823888) | 3M Company | 1983-01-09 |
Recalls involving this device
No recalls on record reference this clearance.