Endo Optiks Urological Catheter for Endoscopy, Model Sessr

FDA 510(k) K083788 · Endooptiks, Inc.

Substantially Equivalent

510(k) numberK083788

Submission

Device name
Endo Optiks Urological Catheter for Endoscopy, Model Sessr
Applicant
Endooptiks, Inc.
Little Silver, NJ, US
Received
December 19, 2008
Decision date
March 3, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EYB – Catheter, Ureteral, Gastro-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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Questions and answers

When was Endo Optiks Urological Catheter for Endoscopy, Model Sessr cleared by the FDA?

Endo Optiks Urological Catheter for Endoscopy, Model Sessr (K083788) received a 510(k) decision of Substantially Equivalent on March 3, 2009, 74 days after the submission was received.

What is the product code of K083788?

The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.