Cleared Traditional

K855077 - ANGIOMED HARZMANN DISCS

K855077 is the FDA 510(k) clearance for ANGIOMED HARZMANN DISCS by Angiomed U.S., Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K855077 · Angiomed U.S., Inc. · Gastroenterology & Urology device
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Jan 1986
Decision
33d
Days
Class 2
Risk

K855077 is an FDA 510(k) clearance for the ANGIOMED HARZMANN DISCS. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on January 21, 1986 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Angiomed U.S., Inc. devices

Submission Details

510(k) Number K855077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1985
Decision Date January 21, 1986
Days to Decision 33 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 130d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 116
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K855077.
NORTA TEFLON COATED LATEX BALLOON CATHETERS
K861181 · Beiersdorf, Inc. · Apr 1986
VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH.
K860337 · Van-Tec, Inc. · Mar 1986
CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
K860484 · The Kendal Co. · Mar 1986
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP
K852084 · The Kendal Co. · Sep 1985
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE
K853207 · American Pharmaseal Div. Ahsc · Sep 1985
TROCAR/CANNULA/SHEATH SET
K853337 · American Edwards Laboratories · Aug 1985