Cleared Traditional

K882963 - SPEMBLY MEDICAL 142 CRYO UNIT

K882963 is an FDA 510(k) clearance for SPEMBLY MEDICAL 142 CRYO UNIT, 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 25-day FDA review.

K882963 · Spembly Medical , Ltd. · General & Plastic Surgery device
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Aug 1988
Decision
25d
Days
Class 2
Risk

K882963 is an FDA 510(k) clearance for the SPEMBLY MEDICAL 142 CRYO UNIT. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Spembly Medical , Ltd. (England, GB). The FDA issued a Cleared decision on August 8, 1988 after a review of 25 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 Spembly Medical , Ltd. devices

FDA 510(k) Submission Details - K882963

510(k) Number K882963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1988
Decision Date August 08, 1988
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
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 211
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K882963.
130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY
K882568 · Spembly Medical , Ltd. · Sep 1988
WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM
K880416 · Wallach Surgical Devices, Inc. · Sep 1988
SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)
K882962 · Spembly Medical , Ltd. · Aug 1988
CRYOPROBES MC-1400-CRYOSURG-CONSOLE
K832385 · Spembly Medical , Ltd. · Sep 1983
CRYOMEDICS 5000 CRYOPROBES
K832140 · Spembly Medical , Ltd. · Aug 1983
CRYOMEDICS 5000 CRYOSURGICAL CONSOLE
K832334 · Spembly Medical , Ltd. · Aug 1983