510(k) K003790 ยท GCJ Laparoscope, General & Plastic Surgery
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
| Applicant | Davol, Inc., Cranston RI, US |
| Decision | Substantially Equivalent, Dec 22, 2000 |
| Received | Dec 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003790
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2022 | Davol, Inc. X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000) Open, Classified |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.