Cleared Traditional

K821616 - CERVISCOPE OPTICAL SYSTEM

K821616 is an FDA 510(k) clearance for CERVISCOPE OPTICAL SYSTEM, manufactured by Fotomedics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K821616 · Fotomedics, Inc. · Obstetrics & Gynecology device
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Jun 1982
Decision
14d
Days
Class 2
Risk

K821616 is an FDA 510(k) clearance for the CERVISCOPE OPTICAL SYSTEM. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Fotomedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1982 after a review of 14 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.

FDA 510(k) Submission Details - K821616

510(k) Number K821616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1982
Decision Date June 16, 1982
Days to Decision 14 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
147d faster than avg
Panel avg: 161d · This submission: 14d
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 53
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K821616.
WALLACH CONVERTIBLE COLPOSCOPE
K871682 · Wallach Surgical Devices, Inc. · Jun 1987
WALLACH ZOOM COLPOSCOPE
K853389 · Wallach Surgical Devices, Inc. · Nov 1985
OCS-2 COLPOSCOPE
K852980 · Olympus Corp. · Oct 1985
KOLPOSKOP KP20005
K791279 · Elmed, Inc. · Sep 1979
COLPOSCOPE SYSTEM
K770697 · Richard Wolf Medical Instruments Corp. · May 1977
DYNATECH JD7/JD7P COLPOSCOPE
K761205 · Dynatech Cryomedical Co. · Dec 1976
K821616 · CERVISCOPE OPTICAL SYSTEM
Download PDF Fotomedics, Inc.