Cleared Traditional

K952895 - CMS URETHRAL WARMER

K952895 is an FDA 510(k) clearance for CMS URETHRAL WARMER, manufactured by Cryomedical Sciences, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K952895 · Cryomedical Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
123d
Days
Class 2
Risk

K952895 is an FDA 510(k) clearance for the CMS URETHRAL WARMER. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryomedical Sciences, Inc. (Rockville, US). The FDA issued a Cleared decision on October 24, 1995 after a review of 123 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K952895

510(k) Number K952895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date October 24, 1995
Days to Decision 123 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 115d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 251
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K952895.
VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION)
K955083 · Cryosurgery, Inc. · Feb 1996
CANDELA CRYO-PROBE HOLDER
K954872 · Candela Laser Corp. · Feb 1996
CMS ACCUPROBE 550/530
K953637 · Cryomedical Sciences, Inc. · Dec 1995
CANDELA CRYOSYSTEM CS-5
K953294 · Candela Laser Corp. · Oct 1995
ENDOCARE CRYOTHERAPY SYSTEM
K942299 · Cytocare, Inc. · Jan 1995
VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED
K944221 · Cryosurgery, Inc. · Dec 1994
K952895 · CMS URETHRAL WARMER
Download PDF FDA Summary Cryomedical Sciences,…