Cleared Traditional

K873552 - CANNULA AND GENERAL PURPOSE ASPIRATOR

K873552 is an FDA 510(k) clearance for CANNULA AND GENERAL PURPOSE ASPIRATOR, manufactured by Cosmedtech, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHI cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K873552 · Cosmedtech, Inc. · Obstetrics & Gynecology device
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Nov 1987
Decision
107d
Days
Class 2
Risk

K873552 is an FDA 510(k) clearance for the CANNULA AND GENERAL PURPOSE ASPIRATOR. Classified as System, Abortion, Vacuum (product code HHI), Class II - Special Controls.

Submitted by Cosmedtech, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on November 25, 1987 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5070 - the FDA obstetrics and gynecology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cosmedtech, Inc. devices

FDA 510(k) Submission Details - K873552

510(k) Number K873552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date November 25, 1987
Days to Decision 107 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 160d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHI Device Classification - Class 2, Special Controls

Product Code HHI System, Abortion, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHI System, Abortion, Vacuum

All 7
Devices cleared under the same product code (HHI) and FDA review panel - the closest regulatory comparables to K873552.
CYTOPREP
K983181 · Cytoprep Inc. Est. · Nov 1998
MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER
K931205 · Baxter Healthcare Corp · Mar 1994
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K880734 · Personal Products Co. · Apr 1988
GYNASPYR VACUUM CURETTAGE UNIT
K850312 · Roseburg SA · Feb 1985
UTERINE VACUM ASPIRATING CURRETTE
K802360 · American Hospital Supply Corp. · Oct 1980