Cleared Traditional

K903213 - ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002

K903213 is an FDA 510(k) clearance for ARTHROSCOPIC SURGICAL KNIVES MODELS 100..., manufactured by Percutaneous Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K903213 · Percutaneous Technologies · Obstetrics & Gynecology device
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Jul 1990
Decision
4d
Days
Class 2
Risk

K903213 is an FDA 510(k) clearance for the ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Percutaneous Technologies (Walnut, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 4 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 Percutaneous Technologies devices

FDA 510(k) Submission Details - K903213

510(k) Number K903213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1990
Decision Date July 27, 1990
Days to Decision 4 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
156d faster than avg
Panel avg: 160d · This submission: 4d
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 34
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K903213.
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
K972630 · CooperSurgical, Inc. · Feb 1998
IMT LOUPE-COLPOSCOPE
K963593 · Inventive Medical Technology · Apr 1997
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
K955635 · Welch Allyn, Inc. · May 1996
MALLEABLE PLACENTA CURETTE
K890387 · Kinetic Medical Products · Feb 1989
JEDMED KP6 COLPOSCOPE
K884934 · Jedmed Instrument Co. · Feb 1989
PHOTOSTAR V-8
K871681 · Wallach Surgical Devices, Inc. · Aug 1987