510(k) Report

FDA applicant

Wallach Surgical Devices, Inc.

Milford, CT27 decisions1981–200216 recalls

FDA records 27 decisions for Wallach Surgical Devices, Inc. (Milford, CT) from 1981 to 2002: 27 510(k) clearances. Most are in product codes HGI (Electrocautery, Gynecologic (And Accessories)) and GEH (Unit, Cryosurgical, Accessories). Its devices cite 17 predicates, 0 of them its own earlier devices. 16 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Wallach Surgical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wallach Surgical Devices, Inc. since 2007.

Recalls per year

8in 2021

2007: 22015: 12019: 52021: 8
2007high 8 (2021) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Wallach Surgical Devices, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wallach Surgical Devices, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HGIElectrocautery, Gynecologic (And Accessories)5decisions
  • GEHUnit, Cryosurgical, Accessories5decisions
  • HEXColposcope (And Colpomicroscope)4decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • HEESet, Anesthesia, Paracervical1decision
  • LMBDevice, Digital Image Storage, Radiological1decision

Also: GEX (1), HHT (1), FLL (1), HIB (1), GXH (1), MFD (1).

Whose devices does it build on?

Its devices cite 17 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K853389Wallach Zoom ColposcopeWallach Surgical Devices, Inc. · 19854cite it
  • K854334Painblocker WA5000Wallach Surgical Devices, Inc. · 19863cite it
  • K935010Wallach Ultra FreezeWallach Surgical Devices, Inc. · 19943cite it
  • K803311LL100 Cryosurgical SystemWallach Surgical Devices, Inc. · 19812cite it
  • K813024WA1000Wallach Surgical Devices, Inc. · 19812cite it
  • K021224Endocervical Block NeedleWallach Surgical Devices, Inc. · 20021cites it

What has FDA decided for it lately?

  • K021224Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
  • K020711Wallach Loop ElectrodeWallach Surgical Devices, Inc. · 20021 recall
  • K000768Wallach Quantum 500 Electrosurgical GeneratorWallach Surgical Devices, Inc. · 2000
  • K992736Wallach's Ultimate Reusable, Plastic Vaginal SpeculumWallach Surgical Devices, Inc. · 1999
  • K991669PMS 750 FingerswitchWallach Surgical Devices, Inc. · 1999
  • K983840Wallach Quantum 500 Electrosurgical Generator (Proposed)Wallach Surgical Devices, Inc. · 1999
  • K984306`the Inseminator' (Proposed)Wallach Surgical Devices, Inc. · 1999
  • K983208Wallach Quantum 500 Electrosurgical GeneratorWallach Surgical Devices, Inc. · 1999

All 27 as Wallach Surgical Devices, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K963653LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120Sep 29, 2021Class II
  • K963653LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220Sep 29, 2021Class II
  • K963653Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05Sep 29, 2021Class II
  • K963653Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05WSep 29, 2021Class II
  • K963348LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120Sep 29, 2021Class II
  • K963348LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220Sep 29, 2021Class II