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FDA 510(k)

FUJIFILM Video Laparoscope EL-R740M30

K-Number: K212950 · 2021-12-02

ApplicantFujifilm Corporaton
Decision Date2021-12-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Video Laparoscope EL-R740M30 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporaton. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K212950. 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 FUJIFILM Video Laparoscope EL-R740M30?

FUJIFILM Video Laparoscope EL-R740M30 is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Fujifilm Corporaton. The 510(k) number is K212950.

When did FUJIFILM Video Laparoscope EL-R740M30 receive FDA 510(k) clearance?

FUJIFILM Video Laparoscope EL-R740M30 received FDA 510(k) clearance on 2021-12-02, under 510(k) number K212950.

Who is the listed applicant for FUJIFILM Video Laparoscope EL-R740M30?

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

What is the FDA product code for FUJIFILM Video Laparoscope EL-R740M30?

The FDA product code for FUJIFILM Video Laparoscope EL-R740M30 is GCJ.

Other records listing Fujifilm Corporaton 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.

K221551FUJIFILM Endoscope Model EI-740D/SK223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DK220957FUJIFILM Endoscope Model EB-710PK203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0K200973Synapse 3D Cardiac Tools

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.

K261139VereSee (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.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

Official Source

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

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