Cleared Traditional

K201970 - Schoelly Cystoscopes/Hysteroscopes and Accessories
(FDA 510(k) Clearance)

K201970 · Schoelly Fiberoptic GmbH · Obstetrics & Gynecology

Oct 2020

Decision

85d

Days

Class 2

Risk

K201970 is an FDA 510(k) clearance for the Schoelly Cystoscopes/Hysteroscopes and Accessories. This device is classified as a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH).

Submitted by Schoelly Fiberoptic GmbH (Denzlingen, DE). The FDA issued a Cleared decision on October 8, 2020, 85 days after receiving the submission on July 15, 2020.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number	K201970 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2020
Decision Date	October 08, 2020
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF