Cleared Traditional

K770383 - STOPCOCK

K770383 is the FDA 510(k) clearance for STOPCOCK by Cobe Laboratories, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770383 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Mar 1977
Decision
7d
Days
Class 2
Risk

K770383 is an FDA 510(k) clearance for the STOPCOCK, ONE WAY. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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 Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K770383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1977
Decision Date March 07, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 130d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOC Accessories, Blood Circuit, Hemodialysis

All 47
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K770383.
TUBE OCCLUDING FORCEPS
K771424 · Quinton, Inc. · Aug 1977
GAMBRO VENOUS BLOOD LINE
K770691 · Gambro, Inc. · Apr 1977
PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2
K770475 · Travenol Laboratories, S.A. · Mar 1977
WINGED FISTULA NEEDLE
K760935 · Gambro, Inc. · Nov 1976
FISTULA NEEDLE (#11-265)
K760665 · Cobe Laboratories, Inc. · Oct 1976
BLOOD TUBING SETS
K760042 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976