EPIDURAL ANESTHESIA NEEDLES
FDA 510(k) clearance K854816 · decided 1985-12-19
Clearance details
- K-number
- K854816
- Device name
- EPIDURAL ANESTHESIA NEEDLES
- Applicant
- Reganes, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-12-03
- Decision date
- 1985-12-19
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic recall (Z-2056-2015) | Integra LifeSciences Corp. d.b.a. Integra Pain Management | 2015-07-09 |
| Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable recall (Z-1544-2015) | Integra LifeSciences Corp. d.b.a. Integra Pain Management | 2015-04-29 |