510(k) K963653 ยท HGI Electrocautery, Gynecologic (And Accessories)
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
| Applicant | Wallach Surgical Devices, Inc., Milford CT, US |
| Decision | Substantially Equivalent, Jun 11, 1997 |
| Received | Sep 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2021 | CooperSurgical, Inc. LEEP PRECISION Generator 120V
Cooper Surgical Part Number: LP-20-120 Open, Classified |
HGI | None listed |
| Sep 29, 2021 | CooperSurgical, Inc. LEEP PRECISION Generator 220V
Cooper Surgical Part Number: LP-20-220 Open, Classified |
HGI | None listed |
| Sep 29, 2021 | CooperSurgical, Inc. Quantum 2000 Electrosurgical Generators
Cooper Surgical Part Number: 909075 Open, Classified |
HGI | None listed |
| Sep 29, 2021 | CooperSurgical, Inc. Quantum 2000 Electrosurgical Generators
Cooper Surgical Part Number: 909075-05 Open, Classified |
HGI | None listed |
| Sep 29, 2021 | CooperSurgical, Inc. Quantum 2000 Electrosurgical Generators
Cooper Surgical Part Number: 909075-05W Open, Classified |
HGI | None listed |
| Oct 16, 2019 | CooperSurgical, Inc. Quantam 2000 Electrosurgical Generator, Part number 909075. Terminated |
HGI | None listed |
| Oct 16, 2019 | CooperSurgical, Inc. Quantam 2000 Electrosurgical Generator, Part number 909075-05. Terminated |
HGI | None listed |
| Oct 16, 2019 | CooperSurgical, Inc. Quantam 2000 Electrosurgical Generator, Part number 909075-05W. Terminated |
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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.