Cleared Traditional

K781863 - DEVICE, FEMALE INCONTINENCE

K781863 is an FDA 510(k) clearance for DEVICE, manufactured by Eschmann Bros. & Walsh , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with 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.

View all Eschmann Bros. & Walsh , Ltd. devices

FDA 510(k) Submission Details - K781863

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.

HHW Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HHW Pessary, Vaginal

All 28
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K781863.
VAGINAL CONTINENCE DEVICE
K930618 · Johnson & Johnson Medical, Inc. · May 1995
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
K933654 · Johnson & Johnson Medical, Inc. · May 1995
FEMALE CONTINENCE DEVICE
K883721 · Cook Ob/Gyn · Oct 1988
SILASTIC BRAND INTRAVAGINAL TARSETTE
K771548 · Dow Corning Corp. Healthcare Industries Materials · Nov 1977