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FDA 510(k)

CARRIER, LIGATURE (79 GEJ)

K-Number: K944465 · 1994-09-28

ApplicantEndotec, Inc.
Decision Date1994-09-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CARRIER, LIGATURE (79 GEJ) is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 1994-09-28 under 510(k) number K944465. 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 CARRIER, LIGATURE (79 GEJ)?

CARRIER, LIGATURE (79 GEJ) is a medical device that received FDA 510(k) clearance on 1994-09-28. The listed applicant is Endotec, Inc.. The 510(k) number is K944465.

When did CARRIER, LIGATURE (79 GEJ) receive FDA 510(k) clearance?

CARRIER, LIGATURE (79 GEJ) received FDA 510(k) clearance on 1994-09-28, under 510(k) number K944465.

Who is the listed applicant for CARRIER, LIGATURE (79 GEJ)?

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

What is the FDA product code for CARRIER, LIGATURE (79 GEJ)?

The FDA product code for CARRIER, LIGATURE (79 GEJ) is GCJ.

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Other records listing Endotec, Inc. as applicant

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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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