Cleared Traditional

K982055 - ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880

K982055 is an FDA 510(k) clearance for ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 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 89-day FDA review.

K982055 · Cryomedical Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
89d
Days
Class 2
Risk

K982055 is an FDA 510(k) clearance for the ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880. 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 September 8, 1998 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cryomedical Sciences, Inc. devices

FDA 510(k) Submission Details - K982055

510(k) Number K982055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1998
Decision Date September 08, 1998
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 K982055.
VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
K982506 · Cryosurgery, Inc. · Jan 1999
CRYOPRO MAXI AND CRYOPRO MINI
K982280 · Cortex Technology Aps · Nov 1998
HISTOFREEZER DEVICE
K982358 · OraSure Technologies, Inc. · Oct 1998
CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
K980668 · Cryomedical Sciences, Inc. · Jul 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