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Verruca-Freeze VFL100

by Cryosurgery, Inc.

Verruca-Freeze VFL100 is a general cryosurgical system (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by Cryosurgery, Inc., cleared under FDA 510(k) K982506 on 27 Jan 1999 and listed in FDA GUDID since 19 Apr 2023 (UDI-DI 00865715000321), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K982506

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00865715000321 UDI-DI Date19 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982506 Date27 Jan 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982506 decided 27 Jan 1999 Active
  • FDA GUDID UDI-DI 00865715000321 listed 19 Apr 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982506
  2. Listed FDA GUDID 00865715000321

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Verruca-Freeze
Generic name
General cryosurgical system, cryogen gas, mechanical
Model / Ref / Catalog
VFL100
Primary DI / UDI-DI
00865715000321
510(k) Number
FDA product code
GEH
GMDN term
General cryosurgical system, cryogen gas, mechanical
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 236 Milliliter

Related devices

Category: General cryosurgical system, cryogen gas, mechanical

Cleared under the same submission (K982506)

and 5 more cleared under K982506

Similar devices

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

Other devices from Cryosurgery, Inc.

See all devices from Cryosurgery, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (12, all answered No)