Cleared Traditional

K955011 - CANDELA HCS 2000 URETHERAL WARMER CATHETER

K955011 is the FDA 510(k) clearance for CANDELA HCS 2000 URETHERAL WARMER CATHETER by Candela Laser Corp.. It is a Class 2 General & Plastic Surgery device (product code GEH) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K955011 · Candela Laser Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
154d
Days
Class 2
Risk

K955011 is an FDA 510(k) clearance for the CANDELA HCS 2000 URETHERAL WARMER CATHETER. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Candela Laser Corp. (Washington, US). The FDA issued a Cleared decision on April 3, 1996 after a review of 154 days - an extended review cycle.

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.

View all Candela Laser Corp. devices

Submission Details

510(k) Number K955011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date April 03, 1996
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 80
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K955011.
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
K051509 · Erbe USA, Inc. · Jul 2005
PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
K970992 · Premier Dental Products Co. · Jun 1997
PERCUTANEOUS INTRODUCER SYSTEM
K961219 · Boston Scientific Corp · Jun 1996
CANDELA CRYO-PROBE HOLDER
K954872 · Candela Laser Corp. · Feb 1996
CANDELA CRYOSYSTEM CS-5
K953294 · Candela Laser Corp. · Oct 1995
MODEL C2100-SERIES OPHTHALMIC CRYOPROBE
K810409 · Valleylab, Inc. · Mar 1981