Cleared Traditional

K760179 - SHEATH

K760179 is the FDA 510(k) clearance for SHEATH by V. Mueller O.V. Baxter Healthcare Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAJ) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K760179 · V. Mueller O.V. Baxter Healthcare Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1976
Decision
149d
Days
Class 2
Risk

K760179 is an FDA 510(k) clearance for the SHEATH, CYSTOURETHROSCOPE W/ OBTURATOR. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1976 after a review of 149 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 V. Mueller O.V. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K760179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date December 02, 1976
Days to Decision 149 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 130d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FAJ Cystoscope And Accessories, Flexible/rigid

All 62
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K760179.
CUSTOMED CYSTO PACK I
K902274 · Customed, Inc. · Sep 1990
LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35
K860822 · Cooper Lasersonics, Inc. · Apr 1986
CURITY ECONOMY II CYSTOSCOPY TRAY
K820851 · The Kendal Co. · May 1982
STOPCOCK, WATERLINE
K760189 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976
TIP, RUBBER, PERFORATED
K760274 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976