Cleared Traditional

K930615 - AUTOVAC CLOSED WOUND SUCTION SYSTEM

K930615 is an FDA 510(k) clearance for AUTOVAC CLOSED WOUND SUCTION SYSTEM, manufactured by Boehringer Laboratories. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K930615 · Boehringer Laboratories · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
382d
Days
Class 1
Risk

K930615 is an FDA 510(k) clearance for the AUTOVAC CLOSED WOUND SUCTION SYSTEM. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K930615

510(k) Number K930615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1993
Decision Date February 22, 1994
Days to Decision 382 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
267d slower than avg
Panel avg: 115d · This submission: 382d
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 87
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K930615.
PENROSE DRAIN MODELS 6001 - 6007
K960099 · Sil-Med Corp. · Mar 1996
MACRO SUCTION TUBE MODEL NO 10061
K950754 · Dlp, Inc. · Apr 1995
PRESSURE IRRIGATING SYSTEM
K936223 · Level 1 Technologies, Inc. · May 1994
BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
K933319 · Birtcher Medical Systems, Inc. · Oct 1993
IMC 5.0MM IRRIGATION/ASPIRATION PROBE
K933305 · Inman Medical Corp. · Oct 1993
IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES
K933306 · Inman Medical Corp. · Oct 1993
K930615 · AUTOVAC CLOSED WOUND SUCTION SYSTEM
Download PDF Boehringer Laboratori…