Cleared Traditional

K913365 - ACCUSCOPE(TM) & ACCUSCOPE II(TM)

K913365 is an FDA 510(k) clearance for ACCUSCOPE(TM) & ACCUSCOPE II(TM), manufactured by Vineland Medical Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K913365 · Vineland Medical Products, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
273d
Days
Class 2
Risk

K913365 is an FDA 510(k) clearance for the ACCUSCOPE(TM) & ACCUSCOPE II(TM). Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Vineland Medical Products, Inc. (Vineland, US). The FDA issued a Cleared decision on April 27, 1992 after a review of 273 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 Vineland Medical Products, Inc. devices

FDA 510(k) Submission Details - K913365

510(k) Number K913365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date April 27, 1992
Days to Decision 273 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 160d · This submission: 273d
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 K913365.
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