Cleared Traditional

K760273 - LITHOTRITE (FDA 510(k) Clearance)

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

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

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1976, 137 days after receiving the submission on July 22, 1976.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4500.

Submission Details

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 —

Device Classification

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