Company ยท US
Wallach Surgical Devices, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2002. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 7 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 5 |
| HEX | Colposcope (And Colpomicroscope) | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| GXH | Device, Surgical, Cryogenic | 1 |
| HEE | Set, Anesthesia, Paracervical | 1 |
| HFF | Aspirator, Endometrial | 1 |
| HHT | Spatula, Cervical, Cytological | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 |
| MFD | Cannula, Intrauterine Insemination | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 12, 2002 | K021224 | ENDOCERVICAL BLOCK NEEDLE Wallach Surgical Devices, Inc. | HEE |
| Jun 3, 2002 | K020711 | WALLACH LOOP ELECTRODE Wallach Surgical Devices, Inc. | GEI |
| Apr 11, 2000 | K000768 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR Wallach Surgical Devices, Inc. | EKZ |
| Sep 29, 1999 | K992736 | WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM Wallach Surgical Devices, Inc. | HIB |
| Aug 12, 1999 | K991669 | PMS 750 FINGERSWITCH Wallach Surgical Devices, Inc. | GEI |
| May 20, 1999 | K983840 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) Wallach Surgical Devices, Inc. | HGI |
| Mar 1, 1999 | K984306 | `THE INSEMINATOR' (PROPOSED) Wallach Surgical Devices, Inc. | MFD |
| Feb 22, 1999 | K983208 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR Wallach Surgical Devices, Inc. | GEI |
| Jun 11, 1997 | K963653 | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM Wallach Surgical Devices, Inc. | HGI |
| Mar 19, 1997 | K963348 | WALLACH INTEGRATION UNIT Wallach Surgical Devices, Inc. | HGI |
| Nov 22, 1995 | K950630 | WALLACH DIGITAL IMAGING SYSTEM Wallach Surgical Devices, Inc. | LMB |
| May 4, 1995 | K921791 | WALLACH LEAP 100 ELECTRO SURGERY SYSTEM Wallach Surgical Devices, Inc. | HGI |
| Feb 28, 1995 | K943201 | CLEAN AIR Wallach Surgical Devices, Inc. | GEX |
| Jul 20, 1994 | K935634 | WALLACH LEEP PROCEDURE KIT Wallach Surgical Devices, Inc. | HGI |
| Feb 9, 1994 | K935010 | WALLACH ULTRA FREEZE Wallach Surgical Devices, Inc. | GEH |
| May 21, 1991 | K910491 | WALLACH COLD SOAKER Wallach Surgical Devices, Inc. | GEH |
| Jan 31, 1991 | K902693 | WALLACH FLEXIBLE ENDOMETRIAL SAMPLER Wallach Surgical Devices, Inc. | HFF |
| Jan 4, 1990 | K896065 | WALLACH CC/BRUSH Wallach Surgical Devices, Inc. | HHT |
| Sep 26, 1988 | K880416 | WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM Wallach Surgical Devices, Inc. | GEH |
| Aug 5, 1987 | K871683 | COLPOSTAR V-6 Wallach Surgical Devices, Inc. | HEX |
| Aug 5, 1987 | K871681 | PHOTOSTAR V-8 Wallach Surgical Devices, Inc. | HEX |
| Jun 24, 1987 | K871682 | WALLACH CONVERTIBLE COLPOSCOPE Wallach Surgical Devices, Inc. | HEX |
| Apr 30, 1986 | K854334 | PAINBLOCKER WA5000 Wallach Surgical Devices, Inc. | GXH |
| Nov 19, 1985 | K853389 | WALLACH ZOOM COLPOSCOPE Wallach Surgical Devices, Inc. | HEX |
| Jan 12, 1982 | K813402 | WA-2000 TEMPERATURE INDICATOR Wallach Surgical Devices, Inc. | FLL |
| Dec 3, 1981 | K813024 | WA1000 Wallach Surgical Devices, Inc. | GEH |
| Feb 4, 1981 | K803311 | LL100 CRYOSURGICAL SYSTEM Wallach Surgical Devices, Inc. | GEH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K803311 |
| 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 | K803311 |