NEEDLE EXTENSIONS
FDA 510(k) clearance K926537 · decided 1994-02-24
Clearance details
- K-number
- K926537
- Device name
- NEEDLE EXTENSIONS
- Applicant
- Thomasville Medical Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-30
- Decision date
- 1994-02-24
- Days to decision
- 421 days
- Clearance type
- Traditional
- Product code
- KNA
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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| DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER (K014248) | Urogyn , Ltd. | 2002-03-21 |
| DND 101 (K001590) | Urogyn , Ltd. | 2000-08-02 |
| DR. JAHANGER'S CUTTER (K990738) | M.S. Jahanger, MD | 1999-10-29 |
| BERACLAMP, MODEL BC-1 (K990045) | Poamax LLC | 1999-05-24 |
| SCC-23 SAFETY CLAMP AND CUTTER (K982464) | Women First Healthcare, Inc. | 1998-08-11 |
Recalls involving this device
No recalls on record reference this clearance.