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FDA 510(k)

SPEEDBAND MULTIPLE BAND LIGATOR

K-Number: K964079 · 1997-02-13

ApplicantBoston Scientific Corp
Decision Date1997-02-13
Product CodeFHN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPEEDBAND MULTIPLE BAND LIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1997-02-13 under 510(k) number K964079. The device is classified under product code FHN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEEDBAND MULTIPLE BAND LIGATOR?

SPEEDBAND MULTIPLE BAND LIGATOR is a medical device that received FDA 510(k) clearance on 1997-02-13. The listed applicant is Boston Scientific Corp. The 510(k) number is K964079.

When did SPEEDBAND MULTIPLE BAND LIGATOR receive FDA 510(k) clearance?

SPEEDBAND MULTIPLE BAND LIGATOR received FDA 510(k) clearance on 1997-02-13, under 510(k) number K964079.

Who is the listed applicant for SPEEDBAND MULTIPLE BAND LIGATOR?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPEEDBAND MULTIPLE BAND LIGATOR?

The FDA product code for SPEEDBAND MULTIPLE BAND LIGATOR is FHN.

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Other records listing Boston Scientific Corp as applicant

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Related Devices (Code: FHN)

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.

K213223Multi-Band LigatorBeijing Zksk Technology Co., Ltd.K172985Ligation DeviceLeo Medical Co., Ltd.K131282NEXUS HEMORRHOID LIGATORInx MedicalK093497THD BANDYThd SpaK091519HAEMOBAND MULTI-LIGATORHaemoband Surgical, Ltd.K070881LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660Sapimed S.P.A.

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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