MICRO DRILLS
FDA 510(k) clearance K821486 · decided 1982-06-09
Clearance details
- K-number
- K821486
- Device name
- MICRO DRILLS
- Applicant
- Spire Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-18
- Decision date
- 1982-06-09
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- GFG
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ventura, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Spire Medical
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 |
|---|---|---|
| MITEK MODULAR DRILL BIT (K935225) | Mitek Surgical Products, Inc. | 1994-04-07 |
| KEY DRILL (K821127) | Key Medical, Inc. | 1982-06-03 |
Recalls involving this device
No recalls on record reference this clearance.