Cleared Traditional

K781863 - DEVICE

K781863 is the FDA 510(k) clearance for DEVICE by Eschmann Bros. & Walsh , Ltd.. It is a Class 2 Obstetrics & Gynecology device (product code HHW) cleared through the Traditional 510(k) pathway .

K781863 · Eschmann Bros. & Walsh , Ltd. · Obstetrics & Gynecology device
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Nov 1978
Decision
-
Days
Class 2
Risk

K781863 is an FDA 510(k) clearance for the DEVICE, FEMALE INCONTINENCE. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Eschmann Bros. & Walsh , Ltd. (Walker, US). The FDA issued a Cleared decision on November 6, 1978.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3575 - 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.

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Submission Details

510(k) Number K781863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received November 06, 1978
Decision Date November 06, 1978
Days to Decision -
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHW Pessary, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3575
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.