Cleared Traditional

MODEL FUS-1, FLEXIBLE URETEROSCOPE

K811535 · American Optical Corp. · Gastroenterology & Urology

Jun 1981

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K811535 is an FDA 510(k) clearance for the MODEL FUS-1, FLEXIBLE URETEROSCOPE, a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on June 23, 1981, 22 days after receiving the submission on June 1, 1981. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K811535 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 1981
Decision Date	June 23, 1981
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—

Device Classification

Product Code	FGB — Ureteroscope And Accessories, Flexible/rigid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).