Cleared Traditional

K881216 - GENT-L-KARE VAGINAL IRRIGATION SET
(FDA 510(k) Clearance)

K881216 · Geneva Laboratories, Inc. · Obstetrics & Gynecology
Jun 1988
Decision
77d
Days
Class 1
Risk

K881216 is an FDA 510(k) clearance for the GENT-L-KARE VAGINAL IRRIGATION SET. This device is classified as a Douche Apparatus, Vaginal, Therapeutic (Class I — General Controls, product code HED).

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on June 7, 1988, 77 days after receiving the submission on March 22, 1988.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5900.

Submission Details

510(k) Number K881216 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 1988
Decision Date June 07, 1988
Days to Decision 77 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HED — Douche Apparatus, Vaginal, Therapeutic
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.5900