LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM

Electrosurgical, Cutting & Coagulation & Accessories

SURGICAL INNOVATIONS PLC

The following data is part of a premarket notification filed by Surgical Innovations Plc with the FDA for Logic Laparoscopic Instrument System.

Pre-market Notification Details

• Device ID: K111986
• 510k Number: K111986
• Device Name: LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: SURGICAL INNOVATIONS PLC CLAYTON WOOD HOUSE, 6 CLAYTON WOOD BANK Leeds, West Yorkshire, GB Ls16 6zq
• Contact: Paul Birtles
• Correspondent: Paul Birtles; SURGICAL INNOVATIONS PLC CLAYTON WOOD HOUSE, 6 CLAYTON WOOD BANK Leeds, West Yorkshire, GB Ls16 6zq
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-13
• Decision Date: 2012-01-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05051986006659	K111986	000
05051986000008	K111986	000
05051986000121	K111986	000
05051986011929	K111986	000
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05051986011257	K111986	000
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05051986000152	K111986	000
05051986000145	K111986	000
05051986000114	K111986	000
05051986007243	K111986	000
05051986007229	K111986	000
05051986009568	K111986	000
05051986009094	K111986	000
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05051986000084	K111986	000
05051986009896	K111986	000
05051986012186	K111986	000
05051986009650	K111986	000
05051986000091	K111986	000
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05051986006949	K111986	000
05051986006918	K111986	000
05051986006901	K111986	000
05051986006772	K111986	000
05051986000268	K111986	000
05051986000176	K111986	000
05051986009926	K111986	000
00501986000121	K111986	000
05051986009346	K111986	000
05051986009087	K111986	000
05051986009070	K111986	000
05051986008608	K111986	000
05051986007854	K111986	000
05051986007922	K111986	000
05051986007885	K111986	000
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05051986006871	K111986	000
05051986006864	K111986	000
05051986006840	K111986	000
05051986006833	K111986	000
05051986006826	K111986	000
05051986006819	K111986	000
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05051986006987	K111986	000
05051986006970	K111986	000
05051986006963	K111986	000
05051986006956	K111986	000
05051986006741	K111986	000