3M FRASCIA STAPLING SYSTEM
FDA 510(k) clearance K823888 · decided 1983-01-09
Clearance details
- K-number
- K823888
- Device name
- 3M FRASCIA STAPLING SYSTEM
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1982-12-27
- Decision date
- 1983-01-09
- Days to decision
- 13 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
- White City, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch 3M Company
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (K854568) | American V. Mueller | 1985-12-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |