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510(k) K060859

COMPOUND W FREEZE OFF WART REMOVAL SYSTEM by OraSure Technologies, Inc. — Product Code GEH

K060859 is an FDA 510(k) premarket notification submitted by OraSure Technologies, Inc. for the device "COMPOUND W FREEZE OFF WART REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 2006. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. OraSure Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2006
Date Received
March 28, 2006
Clearance Type
Special
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 OraSure Technologies, Inc.

  • DEN190025 — OraQuick Ebola Rapid Antigen Test (October 10, 2019)
  • K023487 — HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME (March 20, 2003)
  • K013882 — OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I (April 17, 2002)
  • K020371 — UPLINK TEST SYSTEM (April 3, 2002)
  • K011057 — INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (June 6, 2001)
  • K002375 — STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (January 26, 2001)
  • K001976 — STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (December 6, 2000)
  • K002010 — STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 (November 29, 2000)
  • K000399 — STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (May 15, 2000)
  • K001197 — COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA (May 11, 2000)

Other clearances for product code GEH

  • 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)
  • K253114 — TargetCool™ (RM-DT02W) (October 16, 2025)
  • K253000 — CryoFreeze Wart and Skin Tag Remover (October 16, 2025)

FDA data resources