510(k) K030009 ยท HRX Arthroscope
KSEA POWERSHAVER SYSTEM S2
| Applicant | Karl Storz Endoscopy, Culver City CA, US |
| Decision | Substantially Equivalent, Apr 2, 2003 |
| Received | Jan 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2024 | Karl Storz Endoscopy 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x
3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x
5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x
5.5 x 120 mm R Open, Classified |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.