MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM

Laparoscope, General & Plastic Surgery

SURGICAL INNOVATIONS GROUP PLC

The following data is part of a premarket notification filed by Surgical Innovations Group Plc with the FDA for Modification To: Yelloport Port Access System.

Pre-market Notification Details

• Device ID: K070712
• 510k Number: K070712
• Device Name: MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: SURGICAL INNOVATIONS GROUP PLC CLAYTON PARK CLAYTON WOOD RISE Leeds, GB Ls16,6rf
• Contact: Stuart Moran
• Correspondent: Neil E Devine; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2007-03-14
• Decision Date: 2007-03-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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