Cleared Traditional

K935630 - NORTA

K935630 is an FDA 510(k) clearance for NORTA, manufactured by Beiersdorf, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EZL cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K935630 · Beiersdorf, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
318d
Days
Class 2
Risk

K935630 is an FDA 510(k) clearance for the NORTA. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on October 7, 1994 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K935630

510(k) Number K935630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1993
Decision Date October 07, 1994
Days to Decision 318 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 130d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EZL Device Classification - Class 2, Special Controls

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 63
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K935630.
SILICONE FOLEY CATHETER
K951106 · Cook Urological, Inc. · May 1995
SILASTIC BRAND FOLEY CATHETER
K951103 · C.R. Bard, Inc. · Apr 1995
GLASSMAN SILICONE CATHETER
K934895 · Axiom Medical, Inc. · Oct 1994
SILICONE FOLEY CATHETER
K930344 · Cook Urological, Inc. · Apr 1994
WRP FOLEYCATH
K903777 · Wembley Rubber Products (M) Sdn Bhd · Dec 1990
CURITY 100% SILICONE IRRIGATION FOLEY
K810691 · The Kendal Co. · Mar 1981