Cleared Traditional

K071126 - CRYOSEAL FS APPLICATOR SYSTEM

K071126 is the FDA 510(k) clearance for CRYOSEAL FS APPLICATOR SYSTEM by Thermogenesis Corp.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K071126 · Thermogenesis Corp. · General Hospital
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Aug 2007
Decision
115d
Days
Class 2
Risk

K071126 is an FDA 510(k) clearance for the CRYOSEAL FS APPLICATOR SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Thermogenesis Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on August 16, 2007 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermogenesis Corp. devices

Submission Details

510(k) Number K071126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2007
Decision Date August 16, 2007
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 286
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K071126.
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
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SMALL VOLUME SYRINGE
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B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · B.Braun Medical, Inc. · Aug 2007
TERUMO 31G THINPRO INSULIN SYRINGE
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GENIE, MODEL CH-200
K070633 · Icu Medical, Inc. · Jun 2007