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Histofreezer 1001-0375

by Cryoconcepts, LP

Histofreezer 1001-0375 (60MC2 + 10) is a Class II device made by Cryoconcepts, LP, cleared under FDA 510(k) K990877 on 14 Jun 1999 and listed in FDA GUDID since 22 Sep 2020 (UDI-DI 00850077006128), 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) K990877

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 Number00850077006128 UDI-DI Date22 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK990877 Date14 Jun 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K990877 decided 14 Jun 1999 Active
  • FDA GUDID UDI-DI 00850077006128 listed 22 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K990877
  2. Listed FDA GUDID 00850077006128

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Histofreezer
Generic name
General cryosurgical system, cryogen gas, mechanical
Model / Ref / Catalog
1001-0375, 60MC2 + 10
Primary DI / UDI-DI
00850077006128
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

Related devices

Category: General cryosurgical system, cryogen gas, mechanical

Cleared under the same submission (K990877)

Similar devices

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

Other devices from Cryoconcepts, LP

See all devices from Cryoconcepts, LP →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)