510(k) K911260 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
ATRAUMATIC STANDARD SPROTTE NEEDLE
| Applicant | Pajunk GmbH, Washington DC, US |
| Decision | Substantially Equivalent, Oct 21, 1991 |
| Received | Mar 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911260
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
SPINAL ANESTHESIA KIT/ASA-24090-SB;
SPINAL ANESTHESIA KIT/ASA-24103-SB;
SPINAL ANESTHESIA KIT/ASA-25090-SB;
SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA;
SPINAL ANESTHESIA KIT: 25 Open, Classified |
BSP | None listed |
| Dec 20, 2019 | Arrow International Inc Arrow SPINAL ANESTHESIA SET
ASA-25090-S Terminated |
BSP | None listed |
| Oct 11, 2019 | TELEFLEX MEDICAL INC Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical
The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting inject Open, Classified |
BSP | None listed |
| Oct 11, 2019 | TELEFLEX MEDICAL INC Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical
The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting inject Open, Classified |
BSP | None listed |
| Aug 30, 2019 | Pajunk GmbH SPROTTE Lumbar with Introducer, labeled as the following:
1. Sprotte 22G x 90mm w/ introducer and wings (25/box);
2. Sprotte 22G x 120mm w/ introducer and wings (25/box);
3. Sprotte 19G x 90m Open, Classified |
BSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.