510(k) K915546 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
PS MEDICAL VENTRICULOSTOMY KIT
| Applicant | Pudenz-Schulte Medical Research Corp., Goleta CA, US |
| Decision | Substantially Equivalent, Dec 30, 1991 |
| Received | Dec 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2026 | Medtronic Neurosurgery Ventriculostomy Kit, REF: 46154 Open, Classified |
HBG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.