LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM— 510(k) K111986

Name: FDA 510(k) clearance K111986
Creator: U.S. Food and Drug Administration
Published: 2012-01-26

Substantially Equivalent

Surgical Innovations Plc

FDA 510(k) clearance K111986 for LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM, Substantially Equivalent on 2012-01-26. Applicant: Surgical Innovations Plc. Device class: 2.

Clearance details

Applicant: Surgical Innovations Plc
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2011-07-13
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, W. Yorkshire, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

view all

K254185 — Potenza Prime2026-09-11
K262364 — Ellian Enigma RF Device2026-09-02
K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

More clearances from Surgical Innovations Plc

view all

K123110 — PRETZELFLEX SURGICAL RETRACTOR MODEL SHR73012013-01-17
K112659 — SURGICAL RETRACTORS2012-03-09
K100109 — LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE2010-07-15
K063485 — LOGIC LAPAROSCOPIC SCISSORS2006-12-01
K955393 — NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE1997-01-09

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.