Cleared Traditional

K914015 - CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K914015 · Pilling Co. · General & Plastic Surgery device
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Nov 1991
Decision
73d
Days
Class 1
Risk

K914015 is an FDA 510(k) clearance for the CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP. Classified as Catheter, Cholangiography (product code GBZ), Class I - General Controls.

Submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on November 21, 1991 after a review of 73 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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

Submission Details

510(k) Number K914015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1991
Decision Date November 21, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 114d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBZ Catheter, Cholangiography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.