Cleared Traditional

K771918 - FIBEO OPTICS ILLUM. SYSTEM

K771918 is an FDA 510(k) clearance for FIBEO OPTICS ILLUM. SYSTEM, manufactured by Propper Mfg. Co., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GCP cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K771918 · Propper Mfg. Co., Inc. · Gastroenterology & Urology device
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Oct 1977
Decision
8d
Days
Class 2
Risk

K771918 is an FDA 510(k) clearance for the FIBEO OPTICS ILLUM. SYSTEM. Classified as Endoscope, Ac-powered And Accessories (product code GCP), Class II - Special Controls.

Submitted by Propper Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1977 after a review of 8 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 Propper Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K771918

510(k) Number K771918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1977
Decision Date October 20, 1977
Days to Decision 8 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
122d faster than avg
Panel avg: 130d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCP Device Classification - Class 2, Special Controls

Product Code GCP Endoscope, Ac-powered And Accessories
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 - GCP Endoscope, Ac-powered And Accessories

Devices cleared under the same product code (GCP) and FDA review panel - the closest regulatory comparables to K771918.
STEERABLE CATHETER SYSTEM
K862424 · Endovations · Sep 1986
CCD ENDOSCOPE AND ATTACHMENTS
K801247 · Welch Allyn, Inc. · Jul 1980
ENDOSCOPE AND ACCESSORIES
K790071 · Olympus Corp. · Apr 1979
FIBER OPTICS SIGMOIDOSCOPE
K771919 · Propper Mfg. Co., Inc. · Oct 1977
FIBER OPTICS PROCTOSCOPE
K771920 · Propper Mfg. Co., Inc. · Oct 1977