NEEDLE DRIVER
FDA 510(k) clearance K780255 · decided 1978-04-18
Clearance details
- K-number
- K780255
- Device name
- NEEDLE DRIVER
- Applicant
- Scanlan Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-16
- Decision date
- 1978-04-18
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- GFC
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Scanlan Intl.
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 |
|---|---|---|
| DRIVERS (K781450) | Orthopedic Equipment Co., Inc. | 1978-09-27 |
Recalls involving this device
No recalls on record reference this clearance.