Cleared Traditional

APEX SUCTION CURETTE (K871384) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K871384 · Apex Medical, Inc. · General & Plastic Surgery device
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May 1987
Decision
45d
Days
Class 1
Risk

K871384 is an FDA 510(k) clearance for the APEX SUCTION CURETTE. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Apex Medical, Inc. (Martinsville, US). The FDA issued a Cleared decision on May 22, 1987 after a review of 45 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 Apex Medical, Inc. devices

Submission Details

510(k) Number K871384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date May 22, 1987
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEA Cannula, 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 - GEA Cannula, Surgical, General & Plastic Surgery

All 35
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K871384.
MRI SAFE INSTRUMENTS
K003965 · Aesculap, Inc. · Mar 2001
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
K920110 · Ethicon, Inc. · Apr 1992
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
K911262 · Ethicon, Inc. · Jun 1991
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*
K896434 · United States Surgical, A Division of Tyco Healthc · Nov 1989
CANNULA
K843187 · Ethicon, Inc. · Oct 1984