Cleared Traditional

K873606 - MODIFIED COPE SUTURE ANCHOR

K873606 is an FDA 510(k) clearance for MODIFIED COPE SUTURE ANCHOR, manufactured by Cook, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K873606 · Cook, Inc. · Gastroenterology & Urology device
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Jun 1988
Decision
283d
Days
Class 2
Risk

K873606 is an FDA 510(k) clearance for the MODIFIED COPE SUTURE ANCHOR. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on June 17, 1988 after a review of 283 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

FDA 510(k) Submission Details - K873606

510(k) Number K873606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1987
Decision Date June 17, 1988
Days to Decision 283 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
152d slower than avg
Panel avg: 131d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K873606.
BURNEY GALLBLADDER CATHETER KIT
K880343 · Mallinckrodt Critical Care · May 1989
COOK-GIANTURCO BILIARY Z STENT
K882610 · Cook, Inc. · Apr 1989
EXPANDABLE BILIARY STENT ENDOPROSTHESIS
K885180 · Schneider Intl., Ltd. · Feb 1989
NAMIC HAWKINS UNIVERSAL DRAINAGE SET
K873954 · North American Instrument Corp. · Jan 1988
LINDEN STONE EXTRACTION BALLOON
K872509 · Hobbs Medical, Inc. · Sep 1987
SHEATH, ENDOSCOPE
K862059 · Endovations · Nov 1986