Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InterLock Trocar

K-Number: K170084 · 2017-03-10

ApplicantFujifilm New Development U.S.A., Inc.
Decision Date2017-03-10
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

InterLock Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm New Development U.S.A., Inc.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K170084. 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 InterLock Trocar?

InterLock Trocar is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is Fujifilm New Development U.S.A., Inc.. The 510(k) number is K170084.

When did InterLock Trocar receive FDA 510(k) clearance?

InterLock Trocar received FDA 510(k) clearance on 2017-03-10, under 510(k) number K170084.

Who is the listed applicant for InterLock Trocar?

The FDA 510(k) record lists Fujifilm New Development U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InterLock Trocar?

The FDA product code for InterLock Trocar is GCJ.

Other records listing Fujifilm New Development U.S.A., Inc. 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.

K180414EPX-4440FN Digital Video Processor with Light SourceK162836FUJIFILM Surgical System

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

View on FDA Database →

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

↑