ENDO SMARTCAP

Cystoscope And Accessories, Flexible/rigid

BYRNE MEDICAL INC.

The following data is part of a premarket notification filed by Byrne Medical Inc. with the FDA for Endo Smartcap.

Pre-market Notification Details

• Device ID: K093665
• 510k Number: K093665
• Device Name: ENDO SMARTCAP
• Classification: Cystoscope And Accessories, Flexible/rigid
• Applicant: BYRNE MEDICAL INC. 3150 POLLOK DR Conroe, TX 77303
• Contact: Don Byrne
• Product Code: FAJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2009-11-25
• Decision Date: 2009-12-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04961333241781	K093665	000
00677964059605	K093665	000
00677964059599	K093665	000
00677964059575	K093665	000
00677964059551	K093665	000
00677964059537	K093665	000
00677964059506	K093665	000
00677964059490	K093665	000
00677964059469	K093665	000
00677964059452	K093665	000
00677964059124	K093665	000
00677964059100	K093665	000
00677964059087	K093665	000
00677964060298	K093665	000
20677964060315	K093665	000
20677964060339	K093665	000
04961333241767	K093665	000
04961333241750	K093665	000
00724995219277	K093665	000
00724995219260	K093665	000
00724995219253	K093665	000
00724995219246	K093665	000
40677964013766	K093665	000
40677964013780	K093665	000
40677964013742	K093665	000
40677964013728	K093665	000
40677964013803	K093665	000
40677964013704	K093665	000
00677964057328	K093665	000