Cleared Traditional

K980668 - CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790

K980668 is an FDA 510(k) clearance for CMS BLIZZARD 700 SERIES MODELS 730, 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 147-day FDA review.

K980668 · Cryomedical Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
147d
Days
Class 2
Risk

K980668 is an FDA 510(k) clearance for the CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790. 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 July 17, 1998 after a review of 147 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.

View all Cryomedical Sciences, Inc. devices

FDA 510(k) Submission Details - K980668

510(k) Number K980668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1998
Decision Date July 17, 1998
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
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 K980668.
CRYOPRO MAXI AND CRYOPRO MINI
K982280 · Cortex Technology Aps · Nov 1998
HISTOFREEZER DEVICE
K982358 · OraSure Technologies, Inc. · Oct 1998
ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880
K982055 · Cryomedical Sciences, Inc. · Sep 1998
CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722
K980670 · Cryomedical Sciences, Inc. · Jul 1998
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS
K980739 · OraSure Technologies, Inc. · May 1998
ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM
K980110 · Endocare, Inc. · Apr 1998