ATRAUMATIC STANDARD SPROTTE NEEDLE
FDA 510(k) clearance K911202 · decided 1992-05-04
Clearance details
- K-number
- K911202
- Device name
- ATRAUMATIC STANDARD SPROTTE NEEDLE
- Applicant
- Pajunk GmbH
- Decision
- Substantially Equivalent
- Date received
- 1991-03-19
- Decision date
- 1992-05-04
- Days to decision
- 412 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; S recall (Z-2389-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |