Cleared Traditional

K760183 - OBTURATOR, DEFLECTING

K760183 is an FDA 510(k) clearance for OBTURATOR, manufactured by V. Mueller O.V. Baxter Healthcare Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FEC cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K760183 · V. Mueller O.V. Baxter Healthcare Corp. · Gastroenterology & Urology device
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Dec 1976
Decision
149d
Days
Class 2
Risk

K760183 is an FDA 510(k) clearance for the OBTURATOR, DEFLECTING. Classified as Obturator, For Endoscope (product code FEC), 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

FDA 510(k) Submission Details - K760183

510(k) Number K760183 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
18d slower than avg
Panel avg: 131d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEC Device Classification - Class 2, Special Controls

Product Code FEC Obturator, For Endoscope
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.