Cleared Traditional

K935198 - GASTROENTEROLOGY AND UROLOGY GUIDEWIRE ...

K935198 is an FDA 510(k) clearance for GASTROENTEROLOGY AND UROLOGY GUIDEWIRE ..., manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K935198 · Lake Region Mfg., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
336d
Days
Class 2
Risk

K935198 is an FDA 510(k) clearance for the GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on September 28, 1994 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K935198

510(k) Number K935198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date September 28, 1994
Days to Decision 336 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
206d slower than avg
Panel avg: 130d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 344
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K935198.
MIC DISPOSABLE SNARE
K943685 · Medical Innovations Corp. · Nov 1994
KLEIN RECTAL TAMPNADE BALLOON
K933842 · Cook Urological, Inc. · Sep 1994
MIC TRANSGASTRIC JEJUNAL TUBE
K926581 · Medical Innovations Corp. · Sep 1994
NON-BALLOON REPLACEMENT GASTROSTOMY KIT
K932295 · Biosearch Medical Products, Inc. · Sep 1994
BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
K935045 · Biosearch Medical Products, Inc. · Aug 1994
LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE
K920579 · Wilson-Cook Medical, Inc. · Jul 1994