510(k) K803311 ยท GEH Unit, Cryosurgical, Accessories
LL100 CRYOSURGICAL SYSTEM
| Applicant | Wallach Surgical Devices, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Feb 4, 1981 |
| Received | Jan 2, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K803311
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2015 | CooperSurgical, Inc. WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162 Terminated |
GEH | None listed |
| Jul 11, 2007 | Wallach Surgical Devices, Inc. Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems
Reference: 900218 Terminated |
GEH | None listed |
| Jul 11, 2007 | Wallach Surgical Devices, Inc. Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X
Reference: 900220 Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.