Cleared Traditional

K182764 - Biop Digital Colposcope

K182764 is the FDA 510(k) clearance for Biop Digital Colposcope by Biop Medical , Ltd.. It is a Class 2 Obstetrics & Gynecology device (product code HEX) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K182764 · Biop Medical , Ltd. · Obstetrics & Gynecology device
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Nov 2018
Decision
60d
Days
Class 2
Risk

K182764 is an FDA 510(k) clearance for the Biop Digital Colposcope. Classified as Colposcope (and Colpomicroscope) (product code HEX), Class II - Special Controls.

Submitted by Biop Medical , Ltd. (Ramat-Gan, IL). The FDA issued a Cleared decision on November 27, 2018 after a review of 60 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 Biop Medical , Ltd. devices

Submission Details

510(k) Number K182764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date November 27, 2018
Days to Decision 60 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
100d faster than avg
Panel avg: 160d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HEX Colposcope (and Colpomicroscope)

All 12
Devices cleared under the same product code (HEX) and FDA review panel - the closest regulatory comparables to K182764.
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