510(k) K963348 ยท HGI Electrocautery, Gynecologic (And Accessories)
WALLACH INTEGRATION UNIT
| Applicant | Wallach Surgical Devices, Inc., Milford CT, US |
| Decision | Substantially Equivalent, Mar 19, 1997 |
| Received | Aug 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963348
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2021 | CooperSurgical, Inc. LEEP PRECISION Integrated System, 120V
CooperSurgical part number: LP-10-120 Open, Classified |
HGI | None listed |
| Sep 29, 2021 | CooperSurgical, Inc. LEEP PRECISION Integrated System, 220V
CooperSurgical part numbers: LP-10-220 Open, Classified |
HGI | None listed |
| Jun 18, 2019 | CooperSurgical, Inc. LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120 Terminated |
HGI | None listed |
| Apr 23, 2019 | CooperSurgical, Inc. LEEP Precision Integrated System 120V, Model LP-10-120
Product Usage:
The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEE Terminated |
HGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.