Cleared Traditional

K760647 - ADAPTER, FIBER OPTICS HEADLIGHT

K760647 is an FDA 510(k) clearance for ADAPTER, manufactured by Pilling Co.. The device is a Class 2 Gastroenterology & Urology device with product code FCW cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K760647 · Pilling Co. · Gastroenterology & Urology device
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Dec 1976
Decision
82d
Days
Class 2
Risk

K760647 is an FDA 510(k) clearance for the ADAPTER, FIBER OPTICS HEADLIGHT. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Pilling Co. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1976 after a review of 82 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 Pilling Co. devices

FDA 510(k) Submission Details - K760647

510(k) Number K760647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1976
Decision Date December 06, 1976
Days to Decision 82 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
49d faster than avg
Panel avg: 131d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCW Device Classification - Class 2, Special Controls

Product Code FCW Light Source, Fiberoptic, Routine
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 - FCW Light Source, Fiberoptic, Routine

All 16
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K760647.
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K852951 · Welch Allyn, Inc. · Aug 1985
PEDIATRIC ILLUMINATING URETERAL
K832807 · Van-Tec, Inc. · Oct 1983
PENTAX LH-150F LIGHT SOURCE
K771739 · Pilling Co. · Sep 1977
FLOORSTAND, FIBER OPTIC LIGHT SOURCE
K760176 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976