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FDA 510(k)

ENDOSCOPIC STAPLE REMOVAL INSTRUMENT

K-Number: K010620 · 2001-05-17

ApplicantOnux Medical, Inc.
Decision Date2001-05-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC STAPLE REMOVAL INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Onux Medical, Inc.. It received FDA 510(k) clearance on 2001-05-17 under 510(k) number K010620. 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 ENDOSCOPIC STAPLE REMOVAL INSTRUMENT?

ENDOSCOPIC STAPLE REMOVAL INSTRUMENT is a medical device that received FDA 510(k) clearance on 2001-05-17. The listed applicant is Onux Medical, Inc.. The 510(k) number is K010620.

When did ENDOSCOPIC STAPLE REMOVAL INSTRUMENT receive FDA 510(k) clearance?

ENDOSCOPIC STAPLE REMOVAL INSTRUMENT received FDA 510(k) clearance on 2001-05-17, under 510(k) number K010620.

Who is the listed applicant for ENDOSCOPIC STAPLE REMOVAL INSTRUMENT?

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

What is the FDA product code for ENDOSCOPIC STAPLE REMOVAL INSTRUMENT?

The FDA product code for ENDOSCOPIC STAPLE REMOVAL INSTRUMENT is GCJ.

Related Clinical Trials

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Other records listing Onux Medical, 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.

K023372NON-BIOABSORBABLE STAPLEK022777MANUAL TOUCHE SYSTEMK014286SALUTE, MODEL 3022K003522SALUTE

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

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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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