Cleared Traditional

K921200 - GUIDEWIRE

K921200 is an FDA 510(k) clearance for GUIDEWIRE, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K921200 · Lake Region Mfg., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
176d
Days
Class 2
Risk

K921200 is an FDA 510(k) clearance for the GUIDEWIRE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 176 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 - K921200

510(k) Number K921200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1992
Decision Date September 04, 1992
Days to Decision 176 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
46d slower than avg
Panel avg: 130d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
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 - KNY Accessories, Catheter, G-u

All 23
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K921200.
FLEXI-TRAK ANCHORING DEVICE
K932143 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
URINARY CARE SUPPLIES
K923496 · Orion Life Systems, Inc. · May 1993
HYDROPHILIC COATED GUIDEWIRE
K926344 · Surgitek · Mar 1993
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
K921055 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1992
MENTOR INFUSION LINE
K912919 · Mentor Corp. · Dec 1991
FLEXI-TRAK(TM) ANCHORING DEVICE
K905128 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990