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FDA 510(k)

HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE

K-Number: K013066 · 2001-12-11

ApplicantOlympus America, Inc.
Decision Date2001-12-11
Product CodeMND
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2001-12-11 under 510(k) number K013066. The device is classified under product code MND. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE?

HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE is a medical device that received FDA 510(k) clearance on 2001-12-11. The listed applicant is Olympus America, Inc.. The 510(k) number is K013066.

When did HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE receive FDA 510(k) clearance?

HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE received FDA 510(k) clearance on 2001-12-11, under 510(k) number K013066.

Who is the listed applicant for HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE?

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

What is the FDA product code for HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE?

The FDA product code for HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE is MND.

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Other records listing Olympus America, 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073489OLYMPUS IGA REAGENTK073490OLYMPUS IGG REAGENTK073487OLYMPUS IGM REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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Related Devices (Code: MND)

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.

K132535AUTOBAND LIGATOREndochoice, Inc.K083556MODIFICATION TO AUTO-BAND LIGATORScandimed InternationalK081142AUTO-BAND LIGATORScandimed InternationalK051950INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321Ethicon Endo-Surgery, Inc.K031236AUTO-BAND LIGATORScandimed. A.S.K033245BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700UC.R. Bard, 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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