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FDA 510(k)

LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE

K-Number: K100109 · 2010-07-15

ApplicantSurgical Innovations Plc
Decision Date2010-07-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Innovations Plc. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K100109. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE?

LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Surgical Innovations Plc. The 510(k) number is K100109.

When did LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE receive FDA 510(k) clearance?

LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE received FDA 510(k) clearance on 2010-07-15, under 510(k) number K100109.

Who is the listed applicant for LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE?

The FDA 510(k) record lists Surgical Innovations Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE?

The FDA product code for LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE is GCJ.

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Other records listing Surgical Innovations Plc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123110PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301K112659SURGICAL RETRACTORSK111986LOGIC LAPAROSCOPIC INSTRUMENT SYSTEMK063485LOGIC LAPAROSCOPIC SCISSORSK955393NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPEK962193PORTLAND TROCARS

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Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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