LL100 CRYOSURGICAL SYSTEM
FDA 510(k) clearance K803311 · decided 1981-02-04
Clearance details
- K-number
- K803311
- Device name
- LL100 CRYOSURGICAL SYSTEM
- Applicant
- Wallach Surgical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-01-02
- Decision date
- 1981-02-04
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pin recall (Z-1450-2015) | CooperSurgical, Inc. | 2015-04-16 |
| Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgic recall (Z-1045-2007) | Wallach Surgical Devices, Inc. | 2007-07-11 |
| Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or recall (Z-1046-2007) | Wallach Surgical Devices, Inc. | 2007-07-11 |