# Wallach Surgical Devices, Inc.

- Location (FDA's records): Milford, CT
- FDA decisions: 27 (1981–2002): 27 510(k) clearances
- Product codes: HGI (5), GEH (5), HEX (4), GEI (3), HEE (1), LMB (1), GEX (1), HHT (1), FLL (1), HIB (1), GXH (1), MFD (1)
- Predicates its devices cite: 17 (0 its own); citations of its devices by later devices: 20 (0 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- CooperSurgical, Inc.: 2 (https://510kreport.com/company/coopersurgical)
- A & A Medical, Inc.: 2 (https://510kreport.com/company/a-a-medical)
- Avid Medical, Inc.: 1 (https://510kreport.com/company/avid-medical)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- Nipro Medical Corporation: 1 (https://510kreport.com/company/nipro-medical)
- Adept-Med Intl., Inc.: 1 (https://510kreport.com/company/adept-med-intl)
- Aaron Medical Industries: 1 (https://510kreport.com/company/aaron-medical-industries)
- Medtrex, Inc.: 1 (https://510kreport.com/company/medtrex)

## Firms that cite its devices most
- Crymed Technologies, Inc.: 4 (https://510kreport.com/company/crymed-technologies)
- D.F. Vasconcellos S.A.: 2 (https://510kreport.com/company/df-vasconcellos)
- United Products & Instruments, Inc.: 1 (https://510kreport.com/company/united-products-instruments)
- Intermed Group, Inc.: 1 (https://510kreport.com/company/intermed-group)
- Cryomedical Instruemts, Ltd.: 1 (https://510kreport.com/company/cryomedical-instruemts)
- Medisurg, Ltd.: 1 (https://510kreport.com/company/medisurg)
- Denvu, Inc.: 1 (https://510kreport.com/company/denvu)
- Brymill Cryogenic Systems: 1 (https://510kreport.com/company/brymill-cryogenic-systems)

## Its most-cited devices
- K853389: Wallach Zoom Colposcope (1985), cited by 4
- K854334: Painblocker WA5000 (1986), cited by 3
- K935010: Wallach Ultra Freeze (1994), cited by 3
- K803311: LL100 Cryosurgical System (1981), cited by 2
- K813024: WA1000 (1981), cited by 2
- K021224: Endocervical Block Needle (2002), cited by 1

## Recent decisions
- K021224: Endocervical Block Needle (Jul 12, 2002)
- K020711: Wallach Loop Electrode (Jun 3, 2002)
- K000768: Wallach Quantum 500 Electrosurgical Generator (Apr 11, 2000)
- K992736: Wallach's Ultimate Reusable, Plastic Vaginal Speculum (Sep 29, 1999)
- K991669: PMS 750 Fingerswitch (Aug 12, 1999)
- K983840: Wallach Quantum 500 Electrosurgical Generator (Proposed) (May 20, 1999)
- K984306: `the Inseminator' (Proposed) (Mar 1, 1999)
- K983208: Wallach Quantum 500 Electrosurgical Generator (Feb 22, 1999)

Source page: https://510kreport.com/company/wallach-surgical-devices