Cleared Special

K212655 - Flyte
(FDA 510(k) Clearance)

K212655 · Pelvital USA, Inc. · Gastroenterology & Urology device

Sep 2021

Decision

29d

Days

Class 2

Risk

K212655 is an FDA 510(k) clearance for the Flyte. This device is classified as a Perineometer (Class II - Special Controls, product code HIR).

Submitted by Pelvital USA, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 21, 2021, 29 days after receiving the submission on August 23, 2021.

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

Submission Details

510(k) Number	K212655 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 23, 2021
Decision Date	September 21, 2021
Days to Decision	29 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement