Cleared Traditional

K934261 - ERBOKRYO CA CRYOSURGICAL SYSTEM

K934261 is an FDA 510(k) clearance for ERBOKRYO CA CRYOSURGICAL SYSTEM, manufactured by Erbe Elektromedizin GmbH. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K934261 · Erbe Elektromedizin GmbH · General & Plastic Surgery device
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Apr 1994
Decision
238d
Days
Class 2
Risk

K934261 is an FDA 510(k) clearance for the ERBOKRYO CA CRYOSURGICAL SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Erbe Elektromedizin GmbH (Orange, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 238 days - an extended review 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: 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 Erbe Elektromedizin GmbH devices

FDA 510(k) Submission Details - K934261

510(k) Number K934261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date April 26, 1994
Days to Decision 238 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 115d · This submission: 238d
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 116
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K934261.
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HISTOFREEZER
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HISTOFREEZER
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