Cleared Traditional

HAND MIRROR (ENDOSCOPE)

K862717 · Simpson/Basye, Inc. · Gastroenterology & Urology

Jul 1986

Decision

13d

Days

Class 2

Risk

About This 510(k) Submission

K862717 is an FDA 510(k) clearance for the HAND MIRROR (ENDOSCOPE), a Endoscope, Mirror (Class II — Special Controls, product code GCO), submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on July 30, 1986, 13 days after receiving the submission on July 17, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K862717 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 1986
Decision Date	July 30, 1986
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—