Cleared Traditional

K874342 - LIGATURE CARRIER/PACKER

K874342 is an FDA 510(k) clearance for LIGATURE CARRIER/PACKER, manufactured by Cox-Uphuff Intl.. The device is a Class 1 General & Plastic Surgery device with product code GEJ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K874342 · Cox-Uphuff Intl. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
24d
Days
Class 1
Risk

K874342 is an FDA 510(k) clearance for the LIGATURE CARRIER/PACKER, HYDROXYLAPATITE. Classified as Carrier, Ligature (product code GEJ), Class I - General Controls.

Submitted by Cox-Uphuff Intl. (Santa Barbara, US). The FDA issued a Cleared decision on November 13, 1987 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 Cox-Uphuff Intl. devices

FDA 510(k) Submission Details - K874342

510(k) Number K874342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date November 13, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

GEJ Device Classification - Class 1, General Controls

Product Code GEJ Carrier, Ligature
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.