Cleared Traditional

K873377 - CLOSED CHEST DRAINAGE SET W/SUTURES

K873377 is an FDA 510(k) clearance for CLOSED CHEST DRAINAGE SET W/SUTURES, manufactured by Gish Biomedical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBS cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K873377 · Gish Biomedical, Inc. · General & Plastic Surgery device
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Oct 1987
Decision
65d
Days
Class 1
Risk

K873377 is an FDA 510(k) clearance for the CLOSED CHEST DRAINAGE SET W/SUTURES. Classified as Catheter, Ventricular, General & Plastic Surgery (product code GBS), Class I - General Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 28, 1987 after a review of 65 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K873377

510(k) Number K873377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date October 28, 1987
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

GBS Device Classification - Class 1, General Controls

Product Code GBS Catheter, Ventricular, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBS Catheter, Ventricular, General & Plastic Surgery

All 18
Devices cleared under the same product code (GBS) and FDA review panel - the closest regulatory comparables to K873377.
ATRIUMS PDR THORACIC CATHETER
K912645 · Atrium Medical Corp. · Sep 1991
INTRODUCTION/DRAINAGE CATHETER & ACCESS
K881873 · Sheridan Catheter Corp. · May 1988
URESIL WOUND DRAIN TROCAR
K880895 · Uresil Corp. · Mar 1988
URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA
K863560 · Uresil Corp. · Sep 1986
THORACIC CATHETER (CHEST DRAINAGE TUBE)
K863142 · Sheridan Catheter Corp. · Aug 1986
AXIOM TROCAR THORACIC CATHETER
K863247 · Axiom Medical, Inc. · Aug 1986