Cleared Traditional

K882169 - SURGICAL DUCT CLAMP (VINE)

K882169 is the FDA 510(k) clearance for SURGICAL DUCT CLAMP (VINE) by Henley Intl.. It is a Class 1 General & Plastic Surgery device (product code GDJ) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K882169 · Henley Intl. · General & Plastic Surgery device
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Jun 1988
Decision
24d
Days
Class 1
Risk

K882169 is an FDA 510(k) clearance for the SURGICAL DUCT CLAMP (VINE). Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on June 17, 1988 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Henley Intl. devices

Submission Details

510(k) Number K882169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1988
Decision Date June 17, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDJ Clamp, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.

Regulatory Peers - GDJ Clamp, Surgical, General & Plastic Surgery

All 15
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K882169.
THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE
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AUTO SUTURE PURSE STRING APPLIER*
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K851774 · Artiberia · Jun 1985