Cleared Traditional

K832385 - CRYOPROBES MC-1400-CRYOSURG-CONSOLE

K832385 is an FDA 510(k) clearance for CRYOPROBES MC-1400-CRYOSURG-CONSOLE, manufactured by Spembly Medical , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K832385 · Spembly Medical , Ltd. · General & Plastic Surgery device
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Sep 1983
Decision
55d
Days
Class 2
Risk

K832385 is an FDA 510(k) clearance for the CRYOPROBES MC-1400-CRYOSURG-CONSOLE. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Spembly Medical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 55 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.

FDA 510(k) Submission Details - K832385

510(k) Number K832385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1983
Decision Date September 12, 1983
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
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 263
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K832385.
MC-4000 CONSOLE & PROBES
K842959 · Cryomedics, Inc. · Dec 1984
MT-700 MT-750 FT-350
K842704 · Cryomedics, Inc. · Aug 1984
CRYO SURG 5900
K840536 · Frigitronics of Connecticut, Inc. · Apr 1984
CRYOMEDICS 5000 CRYOPROBES
K832140 · Spembly Medical , Ltd. · Aug 1983
CRYOMEDICS 5000 CRYOSURGICAL CONSOLE
K832334 · Spembly Medical , Ltd. · Aug 1983
WA1000
K813024 · Wallach Surgical Devices, Inc. · Dec 1981
K832385 · CRYOPROBES MC-1400-CRYOSURG-CONSOLE
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