Cleared Traditional

K013612 - INCARE PELVIC FLOOR THERAPY SYSTEM
(FDA 510(k) Clearance)

K013612 · Hollister, Inc. · Gastroenterology & Urology device

Mar 2002

Decision

134d

Days

Class 2

Risk

K013612 is an FDA 510(k) clearance for the INCARE PELVIC FLOOR THERAPY SYSTEM. This device is classified as a Perineometer (Class II - Special Controls, product code HIR).

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on March 19, 2002, 134 days after receiving the submission on November 5, 2001.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.1425.

Submission Details

510(k) Number	K013612 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 2001
Decision Date	March 19, 2002
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF