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CryoClear 801-2001

by Cryoconcepts, LP

CryoClear 801-2001 is a Class II device made by Cryoconcepts, LP, cleared under FDA 510(k) K102006 on 6 Oct 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00850077006050), 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) K102006

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 Number00850077006050 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102006 Date6 Oct 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102006 decided 6 Oct 2010 Active
  • FDA GUDID UDI-DI 00850077006050 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K102006
  2. Listed FDA GUDID 00850077006050

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CryoClear
Generic name
Cryogenic spray, cutaneous
Model / Ref / Catalog
801-2001
Primary DI / UDI-DI
00850077006050
510(k) Number
FDA product code
GEH
GMDN term
Cryogenic spray, cutaneous
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution
Size
Weight — 8 Gram

Related devices

Category: Cryogenic spray, cutaneous

Cleared under the same submission (K102006)

and 3 more cleared under K102006

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
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)