Cleared Traditional

K851196 - INCISION DRAIN

K851196 is an FDA 510(k) clearance for INCISION DRAIN, manufactured by Sil-Med Corp.. The device is a Class 1 General & Plastic Surgery device with product code GCD cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K851196 · Sil-Med Corp. · General & Plastic Surgery device
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Jun 1985
Decision
70d
Days
Class 1
Risk

K851196 is an FDA 510(k) clearance for the INCISION DRAIN. Classified as Connector, Catheter (product code GCD), Class I - General Controls.

Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on June 4, 1985 after a review of 70 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 Sil-Med Corp. devices

FDA 510(k) Submission Details - K851196

510(k) Number K851196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date June 04, 1985
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

GCD Device Classification - Class 1, General Controls

Product Code GCD Connector, Catheter
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 - GCD Connector, Catheter

Devices cleared under the same product code (GCD) and FDA review panel - the closest regulatory comparables to K851196.
L-CATH CONNECTOR ASSEMBLY
K940198 · Luther Medical Products, Inc. · Dec 1994
ANGIOMED HIGH PRESSURE CONNECTORS
K863446 · Angiomed U.S., Inc. · Sep 1986
Y CONNECTOR
K851921 · Sil-Med Corp. · May 1985
CATHETER CONNECTOR, ARGYLE TUBING
K760524 · Sherwood Medical Industries · Nov 1976
TUBE, STERILE NON-CONDUCTIVE CONNECTING
K760203 · Ipco Corp. · Jul 1976