510(k) K014158 ยท GCJ Laparoscope, General & Plastic Surgery
ENDOSCOPIC CAMERA TC804/C4
| Applicant | World of Medicine Lemke GmbH, Cambridge MA, US |
| Decision | Substantially Equivalent, Mar 14, 2002 |
| Received | Dec 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2011 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, HD1200 Autoclavable Camera Head
Catalog Number: 72203360
Product Usage: Endoscope & Accessories Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.