Cleared Traditional

K890387 - MALLEABLE PLACENTA CURETTE

K890387 is an FDA 510(k) clearance for MALLEABLE PLACENTA CURETTE, manufactured by Kinetic Medical Products. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K890387 · Kinetic Medical Products · Obstetrics & Gynecology device
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Feb 1989
Decision
35d
Days
Class 2
Risk

K890387 is an FDA 510(k) clearance for the MALLEABLE PLACENTA CURETTE. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1630 - 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: 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 Kinetic Medical Products devices

FDA 510(k) Submission Details - K890387

510(k) Number K890387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date February 27, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 160d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEX Device Classification - Class 2, Special Controls

Product Code HEX Colposcope (and Colpomicroscope)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1630
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 - HEX Colposcope (and Colpomicroscope)

All 17
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K890387.
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc. · Mar 2004
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
K972630 · CooperSurgical, Inc. · Feb 1998
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
K955635 · Welch Allyn, Inc. · May 1996
JEDMED KP6 COLPOSCOPE
K884934 · Jedmed Instrument Co. · Feb 1989
PHOTOSTAR V-8
K871681 · Wallach Surgical Devices, Inc. · Aug 1987
COLPOSTAR V-6
K871683 · Wallach Surgical Devices, Inc. · Aug 1987