Cleared Traditional

K991426 - MAHE INSTRUMENTS

K991426 is an FDA 510(k) clearance for MAHE INSTRUMENTS, manufactured by Mahe Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K991426 · Mahe Intl., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
104d
Days
Class 2
Risk

K991426 is an FDA 510(k) clearance for the MAHE INSTRUMENTS. Classified as Resectoscope, Working Element (product code FDC), Class II - Special Controls.

Submitted by Mahe Intl., Inc. (Nashville, US). The FDA issued a Cleared decision on August 5, 1999 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Mahe Intl., Inc. devices

FDA 510(k) Submission Details - K991426

510(k) Number K991426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1999
Decision Date August 05, 1999
Days to Decision 104 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 130d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDC Device Classification - Class 2, Special Controls

Product Code FDC Resectoscope, Working Element
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - FDC Resectoscope, Working Element

Devices cleared under the same product code (FDC) and FDA review panel - the closest regulatory comparables to K991426.
OLYMPUS WORKING ELEMENT FOR PROBES
K992141 · Olympus Winter & Ibe GmbH · Sep 1999
SHEATH, RESECTOSCOPE
K760182 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976
ELEMENT, WORKING
K760184 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976
ADAPTER, RESECTOSCOPE
K760174 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976