Cleared Traditional

K880416 - WCCS 800 WALLACH CARDIAC CRYOSURGICAL S...

K880416 is the FDA 510(k) clearance for WCCS 800 WALLACH CARDIAC CRYOSURGICAL S... by Wallach Surgical Devices, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEH) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K880416 · Wallach Surgical Devices, Inc. · General & Plastic Surgery device
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Sep 1988
Decision
238d
Days
Class 2
Risk

K880416 is an FDA 510(k) clearance for the WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Wallach Surgical Devices, Inc. (Milford, US). The FDA issued a Cleared decision on September 26, 1988 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 Wallach Surgical Devices, Inc. devices

Submission Details

510(k) Number K880416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1988
Decision Date September 26, 1988
Days to Decision 238 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
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.

Device Classification

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 90
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