Cleared Traditional

K892000 - FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE

K892000 is an FDA 510(k) clearance for FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE, manufactured by Schott Fiber Optics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAM cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K892000 · Schott Fiber Optics, Inc. · Gastroenterology & Urology device
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Apr 1989
Decision
28d
Days
Class 2
Risk

K892000 is an FDA 510(k) clearance for the FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE. Classified as Sigmoidoscope And Accessories, Flexible/rigid (product code FAM), Class II - Special Controls.

Submitted by Schott Fiber Optics, Inc. (Southbridge, US). The FDA issued a Cleared decision on April 25, 1989 after a review of 28 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 Schott Fiber Optics, Inc. devices

FDA 510(k) Submission Details - K892000

510(k) Number K892000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date April 25, 1989
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAM Device Classification - Class 2, Special Controls

Product Code FAM Sigmoidoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Sigmoid (descending) Colon
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 - FAM Sigmoidoscope And Accessories, Flexible/rigid

All 20
Devices cleared under the same product code (FAM) and FDA review panel - the closest regulatory comparables to K892000.
FS-38H, FIBER SIGMOIDOSCOPE
K951573 · Pentax Precision Instrument Corp. · Jun 1995
FLEXIBLE VIDEO SIGMOIDOSCOPE SYSTEM W/DISP. SHEATH
K932843 · Vision-Sciences, Inc. · Feb 1994
FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM
K921690 · Vision-Sciences, Inc. · Oct 1992
FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3
K820790 · American Optical Corp. · Apr 1982
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE
K812965 · American Optical Corp. · Nov 1981
PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34
K792341 · Pentax Precision Instrument Corp. · Dec 1979