Cleared Traditional

K963593 - IMT LOUPE-COLPOSCOPE

K963593 is an FDA 510(k) clearance for IMT LOUPE-COLPOSCOPE, manufactured by Inventive Medical Technology. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K963593 · Inventive Medical Technology · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
225d
Days
Class 2
Risk

K963593 is an FDA 510(k) clearance for the IMT LOUPE-COLPOSCOPE. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Inventive Medical Technology (Trappe, US). The FDA issued a Cleared decision on April 22, 1997 after a review of 225 days - an extended review 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: 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 Inventive Medical Technology devices

FDA 510(k) Submission Details - K963593

510(k) Number K963593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1996
Decision Date April 22, 1997
Days to Decision 225 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 160d · This submission: 225d
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 29
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K963593.
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
K992544 · Circon Corp. · Oct 1999
LEISEGANG VIDEO COLPOSCOPE
K981958 · Netoptix Corp. · Oct 1998
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
K972630 · CooperSurgical, Inc. · Feb 1998
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