Cleared Traditional

K780848 - PORTABLE CLOSED WOUND SUCTION EVACUATOR

K780848 is an FDA 510(k) clearance for PORTABLE CLOSED WOUND SUCTION EVACUATOR, manufactured by Biomet, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K780848 · Biomet, Inc. · General & Plastic Surgery device
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Aug 1978
Decision
92d
Days
Class 1
Risk

K780848 is an FDA 510(k) clearance for the PORTABLE CLOSED WOUND SUCTION EVACUATOR. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 23, 1978 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4680 - 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.

FDA 510(k) Submission Details - K780848

510(k) Number K780848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1978
Decision Date August 23, 1978
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

GCY Device Classification - Class 1, General Controls

Product Code GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4680
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

All 88
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K780848.
ROUND SILICONE DRAIN
K782028 · Davol, Inc. · Dec 1978
FLAT SILICONE DRAIN
K782026 · Davol, Inc. · Dec 1978
HEMOVAC TUBING MATERIAL CHANGE
K781400 · Snyder Laboratories, Inc. · Sep 1978
VYGON RED-O-PACK
K771015 · Coastal Bend Medical Products, Inc. · Jul 1977
T-TUBE DRAIN, ROUND
K760778 · Heyer Schulte Corp. · Nov 1976
SILASTIC BRAND G7-2090A
K760700 · Dow Corning Corp. Healthcare Industries Materials · Nov 1976
K780848 · PORTABLE CLOSED WOUND SUCTION EVACUATOR
Download PDF Biomet, Inc.