Cleared Traditional

K844773 - EFF-EFFNER BULBS

K844773 is an FDA 510(k) clearance for EFF-EFFNER BULBS, manufactured by Mecron Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFS cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K844773 · Mecron Medical Products, Inc. · Gastroenterology & Urology device
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Jan 1985
Decision
29d
Days
Class 2
Risk

K844773 is an FDA 510(k) clearance for the EFF-EFFNER BULBS. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by Mecron Medical Products, Inc. (Port Washington, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 29 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 Mecron Medical Products, Inc. devices

FDA 510(k) Submission Details - K844773

510(k) Number K844773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1984
Decision Date January 08, 1985
Days to Decision 29 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: 131d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFS Device Classification - Class 2, Special Controls

Product Code FFS Image, Illumination, Fiberoptic, 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.

Regulatory Peers - FFS Image, Illumination, Fiberoptic, For Endoscope

All 15
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K844773.
KARL STORZ ENDOSCOPY-AMERICA, INC.
K933216 · KARL STORZ Endoscopy-America, Inc. · Sep 1993
FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
K893440 · Welch Allyn, Inc. · Jul 1989
LIGHT SOURCE, ENDOSCOP, XENON ARC
K890448 · Mira, Inc. · May 1989
FLEXIBLE LIQUID LIGHT GUIDE
K834487 · Endo Lase, Inc. · Feb 1984