Cleared Traditional

K964047 - CRYOSIL SILICONE GEL SHEETING

K964047 is an FDA 510(k) clearance for CRYOSIL SILICONE GEL SHEETING, manufactured by Biodermis Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K964047 · Biodermis Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
161d
Days
Class 2
Risk

K964047 is an FDA 510(k) clearance for the CRYOSIL SILICONE GEL SHEETING. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Biodermis Corp. (Las Vegas, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 161 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 Biodermis Corp. devices

FDA 510(k) Submission Details - K964047

510(k) Number K964047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1996
Decision Date March 19, 1997
Days to Decision 161 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 115d · This submission: 161d
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 164
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K964047.
FRIGIDERM FRIGISPRAY
K971216 · Dermatologic Lab & Supply, Inc. · May 1997
CRYOGEN CRYOSURGICAL SYSTEM
K964971 · Cryogen, Inc. · Mar 1997
CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680
K964336 · Cryomedical Sciences, Inc. · Mar 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
K963970 · Endocare, Inc. · Feb 1997
ENDOCARE CRYCARE CRYOSURGICAL SYSTEM
K963826 · Endocare, Inc. · Dec 1996
PERCUTANEOUS INTRODUCER SYSTEM
K961219 · Boston Scientific Corp · Jun 1996