UNIVERSAL IRRIGATION SOLUTION HYBRID

Endoscopic Irrigation/suction System

BYRNE MEDICAL, INC.

The following data is part of a premarket notification filed by Byrne Medical, Inc. with the FDA for Universal Irrigation Solution Hybrid.

Pre-market Notification Details

• Device ID: K102855
• 510k Number: K102855
• Device Name: UNIVERSAL IRRIGATION SOLUTION HYBRID
• Classification: Endoscopic Irrigation/suction System
• Applicant: BYRNE MEDICAL, INC. 3150 POLLOCK DR. Conroe, TX 77303
• Contact: John Willis
• Correspondent: John Willis; BYRNE MEDICAL, INC. 3150 POLLOCK DR. Conroe, TX 77303
• Product Code: OCX
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-29
• Decision Date: 2010-11-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10724995224032	K102855	000
40677964027992	K102855	000
40677964028111	K102855	000
40677964028142	K102855	000
20677964067284	K102855	000
00677964052354	K102855	000
00677964052361	K102855	000
20677964052433	K102855	000
20677964052440	K102855	000
20677964056486	K102855	000
20677964056493	K102855	000
20677964056509	K102855	000
20677964056516	K102855	000
20677964056523	K102855	000
40677964011205	K102855	000
10677964059640	K102855	000
10724995224056	K102855	000
10724995224186	K102855	000
10724995224209	K102855	000
50724995224221	K102855	000
40677964031524	K102855	000
50724995224078	K102855	000
50724995224092	K102855	000
10724995224117	K102855	000
50724995224139	K102855	000
10724995224155	K102855	000
50724995224177	K102855	000
10724995224193	K102855	000
50724995224214	K102855	000
20677964056882	K102855	000
20677964056899	K102855	000
20677964056905	K102855	000
20677964065334	K102855	000
20677964065341	K102855	000
20677964065358	K102855	000
20677964065365	K102855	000
20677964065372	K102855	000
00677964067358	K102855	000
20677964067376	K102855	000
20677964067383	K102855	000
20677964068946	K102855	000
20677964068953	K102855	000
20677964070437	K102855	000
20677964070468	K102855	000
00677964081972	K102855	000
20677964065327	K102855	000
20677964065310	K102855	000
20677964056912	K102855	000
20677964056929	K102855	000
20677964056936	K102855	000
20677964056943	K102855	000
20677964056950	K102855	000
20677964056967	K102855	000
00677964060106	K102855	000
00677964060113	K102855	000
00677964060830	K102855	000
20677964060858	K102855	000
00677964060861	K102855	000
20677964065297	K102855	000
20677964065303	K102855	000
00677964081989	K102855	000