Cleared Traditional

K854905 - PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)

K854905 is an FDA 510(k) clearance for PERCUTANEOUS NEPHROSTOMY SETS (LOOP TEC..., manufactured by Angiomed U.S., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBO cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K854905 · Angiomed U.S., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
46d
Days
Class 1
Risk

K854905 is an FDA 510(k) clearance for the PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE). Classified as Catheter, Nephrostomy, General & Plastic Surgery (product code GBO), Class I - General Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on January 24, 1986 after a review of 46 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 - K854905

510(k) Number K854905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1985
Decision Date January 24, 1986
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

GBO Device Classification - Class 1, General Controls

Product Code GBO Catheter, Nephrostomy, General & Plastic Surgery
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 - GBO Catheter, Nephrostomy, General & Plastic Surgery

All 9
Devices cleared under the same product code (GBO) and FDA review panel - the closest regulatory comparables to K854905.
MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
K041995 · Uresil, LLC · Aug 2004
URESIL GENERAL PURPOSE DRAINAGE CATHETER
K912109 · Uresil Corp. · Aug 1991
PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
K854906 · Angiomed U.S., Inc. · Jan 1986
PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
K854907 · Angiomed U.S., Inc. · Jan 1986
PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS
K854909 · Angiomed U.S., Inc. · Jan 1986
PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)
K854911 · Angiomed U.S., Inc. · Jan 1986