Cleared Traditional

K860534 - BILE ENDOPROSTHESIS SET

K860534 is an FDA 510(k) clearance for BILE ENDOPROSTHESIS SET, manufactured by Angiomed U.S., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBZ cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K860534 · Angiomed U.S., Inc. · General & Plastic Surgery device
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Mar 1986
Decision
26d
Days
Class 1
Risk

K860534 is an FDA 510(k) clearance for the BILE ENDOPROSTHESIS SET. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on March 10, 1986 after a review of 26 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 Angiomed U.S., Inc. devices

FDA 510(k) Submission Details - K860534

510(k) Number K860534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1986
Decision Date March 10, 1986
Days to Decision 26 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
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

GBZ Device Classification - Class 1, General Controls

Product Code GBZ Catheter, Cholangiography
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 - GBZ Catheter, Cholangiography

All 17
Devices cleared under the same product code (GBZ) and FDA review panel - the closest regulatory comparables to K860534.
CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP
K914015 · Pilling Co. · Nov 1991
SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH
K903709 · Lifestream Int'L, Inc. · Oct 1990
MENTOR DUCTAL CATHETERS
K895285 · Mentor Corp. · Oct 1989
ATRIUM THORACIC CATHETER
K831931 · Atrium Medical Corp. · Oct 1983
CATHETER, CHOLANGIOGRAM, OPERATIVE
K772288 · Gesco Intl., Inc. · Jan 1978