Cleared Traditional

K191294 - Transvaginal Access Platform (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191294 · Applied Medical Resources Corp. · Obstetrics & Gynecology device
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Sep 2019
Decision
115d
Days
Class 2
Risk

K191294 is an FDA 510(k) clearance for the Transvaginal Access Platform. Classified as Culdoscope (and Accessories) (product code HEW), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on September 6, 2019 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1640 - 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 Applied Medical Resources Corp. devices

Submission Details

510(k) Number K191294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2019
Decision Date September 06, 2019
Days to Decision 115 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 160d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HEW Culdoscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1640
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.