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510(k) K910491

WALLACH COLD SOAKER by Wallach Surgical Devices, Inc. — Product Code GEH

K910491 is an FDA 510(k) premarket notification submitted by Wallach Surgical Devices, Inc. for the device "WALLACH COLD SOAKER". The FDA issued a decision of Substantially Equivalent on May 21, 1991. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Wallach Surgical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1991
Date Received
February 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Wallach Surgical Devices, Inc.

  • K021224 — ENDOCERVICAL BLOCK NEEDLE (July 12, 2002)
  • K020711 — WALLACH LOOP ELECTRODE (June 3, 2002)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K992736 — WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM (September 29, 1999)
  • K991669 — PMS 750 FINGERSWITCH (August 12, 1999)
  • K983840 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) (May 20, 1999)
  • K984306 — `THE INSEMINATOR' (PROPOSED) (March 1, 1999)
  • K983208 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (February 22, 1999)
  • K963653 — WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM (June 11, 1997)
  • K963348 — WALLACH INTEGRATION UNIT (March 19, 1997)

Other clearances for product code GEH

  • K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) (September 2, 2026)
  • K261068 — Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (June 30, 2026)
  • K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories (June 9, 2026)
  • K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe (April 22, 2026)
  • K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (April 2, 2026)
  • K260377 — XSense Cryoablation System with CryoProbes (February 24, 2026)
  • K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control (February 13, 2026)
  • K251524 — Dr. Yglo Skin Tag Remover (January 12, 2026)
  • K250742 — Focused Cryotherapy System (December 9, 2025)
  • K253000 — CryoFreeze Wart and Skin Tag Remover (October 16, 2025)

FDA data resources