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FDA 510(k)

HX-20/21-1 ENDOSCOPIC LIGATOR

K-Number: K964661 · 1997-10-30

ApplicantOlympus America, Inc.
Decision Date1997-10-30
Product CodeMND
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HX-20/21-1 ENDOSCOPIC LIGATOR 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 1997-10-30 under 510(k) number K964661. 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-20/21-1 ENDOSCOPIC LIGATOR?

HX-20/21-1 ENDOSCOPIC LIGATOR is a medical device that received FDA 510(k) clearance on 1997-10-30. The listed applicant is Olympus America, Inc.. The 510(k) number is K964661.

When did HX-20/21-1 ENDOSCOPIC LIGATOR receive FDA 510(k) clearance?

HX-20/21-1 ENDOSCOPIC LIGATOR received FDA 510(k) clearance on 1997-10-30, under 510(k) number K964661.

Who is the listed applicant for HX-20/21-1 ENDOSCOPIC LIGATOR?

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-20/21-1 ENDOSCOPIC LIGATOR?

The FDA product code for HX-20/21-1 ENDOSCOPIC LIGATOR 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 ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA 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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