Cleared Traditional

K760177 - TELESCOPE, RIGID ENDOSCOPE

K760177 is an FDA 510(k) clearance for TELESCOPE, manufactured by V. Mueller O.V. Baxter Healthcare Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FBP cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K760177 · V. Mueller O.V. Baxter Healthcare Corp. · Gastroenterology & Urology device
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Aug 1976
Decision
55d
Days
Class 2
Risk

K760177 is an FDA 510(k) clearance for the TELESCOPE, RIGID ENDOSCOPE. Classified as Telescope, Rigid, Endoscopic (product code FBP), Class II - Special Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1976 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all V. Mueller O.V. Baxter Healthcare Corp. devices

FDA 510(k) Submission Details - K760177

510(k) Number K760177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date August 30, 1976
Days to Decision 55 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
76d faster than avg
Panel avg: 131d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBP Device Classification - Class 2, Special Controls

Product Code FBP Telescope, Rigid, Endoscopic
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 - FBP Telescope, Rigid, Endoscopic

Devices cleared under the same product code (FBP) and FDA review panel - the closest regulatory comparables to K760177.
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