Cleared Traditional

K872214 - COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS

K872214 is an FDA 510(k) clearance for COOPER SURG ASPIRATION CANNULA/CUSTOM C..., manufactured by CooperVision, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K872214 · CooperVision, Inc. · General & Plastic Surgery device
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Aug 1987
Decision
69d
Days
Class 1
Risk

K872214 is an FDA 510(k) clearance for the COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on August 17, 1987 after a review of 69 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.

FDA 510(k) Submission Details - K872214

510(k) Number K872214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1987
Decision Date August 17, 1987
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

GEA Device Classification - Class 1, General Controls

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 K872214.
CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC
K895762 · Kolster Methods · Oct 1989
SURGICAL SUCTION APPARATUS
K895670 · Baker-Sundt Research, Inc. · Sep 1989
L-5 PLASTIC SURGERY CANNULAS
K880669 · American Instrument Manufacturer'S, Inc. · Mar 1988
SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE
K872906 · American Silk Sutures, Inc. · Aug 1987
APEX SUCTION CURETTE
K871384 · Apex Medical, Inc. · May 1987
(I) LV AND (II) HV SERIES CANNULA
K871043 · Celebration Medical Products, Inc. · Apr 1987
K872214 · COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
Download PDF CooperVision, Inc.