Cleared Traditional

K993953 - OVES CERVICAL CAP

K993953 is an FDA 510(k) clearance for OVES CERVICAL CAP, manufactured by Veos , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HDR cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K993953 · Veos , Ltd. · Obstetrics & Gynecology device
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Mar 2000
Decision
120d
Days
Class 2
Risk

K993953 is an FDA 510(k) clearance for the OVES CERVICAL CAP. Classified as Cap, Cervical (product code HDR), Class II - Special Controls.

Submitted by Veos , Ltd. (Lake Forest, US). The FDA issued a Cleared decision on March 21, 2000 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - 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 Veos , Ltd. devices

FDA 510(k) Submission Details - K993953

510(k) Number K993953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 22, 1999
Decision Date March 21, 2000
Days to Decision 120 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 160d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDR Device Classification - Class 2, Special Controls

Product Code HDR Cap, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
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 - HDR Cap, Cervical

All 14
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