Cleared Traditional

K760273 - LITHOTRITE

K760273 is an FDA 510(k) clearance for LITHOTRITE, manufactured by V. Mueller O.V. Baxter Healthcare Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGK cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K760273 · V. Mueller O.V. Baxter Healthcare Corp. · Gastroenterology & Urology device
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Dec 1976
Decision
137d
Days
Class 2
Risk

K760273 is an FDA 510(k) clearance for the LITHOTRITE. Classified as Tripsor, Stone, Bladder (product code FGK), Class II - Special Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1976 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4500 - 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

FDA 510(k) Submission Details - K760273

510(k) Number K760273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1976
Decision Date December 06, 1976
Days to Decision 137 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
6d slower than avg
Panel avg: 131d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGK Device Classification - Class 2, Special Controls

Product Code FGK Tripsor, Stone, Bladder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4500
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.