YelloPort Elite Port Access System

Laparoscope, General & Plastic Surgery

Surgical Innovations Limited

The following data is part of a premarket notification filed by Surgical Innovations Limited with the FDA for Yelloport Elite Port Access System.

Pre-market Notification Details

• Device ID: K190592
• 510k Number: K190592
• Device Name: YelloPort Elite Port Access System
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: Surgical Innovations Limited Clayton Wood House 6 Clayton Wood Bank Leeds, GB Ls16 6qz
• Contact: Shazia Chaudhry
• Correspondent: Shazia Chaudhry; Surgical Innovations Limited Clayton Wood House 6 Clayton Wood Bank Leeds, GB Ls16 6qz
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-07
• Decision Date: 2019-04-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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05051986013572	K190592	000