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FDA 510(k)

O'REGAN LIGATOR

K-Number: K963166 · 1997-05-05

ApplicantPatrick J. O'Regan
Decision Date1997-05-05
Product CodeFHN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

O'REGAN LIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Patrick J. O'Regan. It received FDA 510(k) clearance on 1997-05-05 under 510(k) number K963166. 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 O'REGAN LIGATOR?

O'REGAN LIGATOR is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is Patrick J. O'Regan. The 510(k) number is K963166.

When did O'REGAN LIGATOR receive FDA 510(k) clearance?

O'REGAN LIGATOR received FDA 510(k) clearance on 1997-05-05, under 510(k) number K963166.

Who is the listed applicant for O'REGAN LIGATOR?

The FDA 510(k) record lists Patrick J. O'Regan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O'REGAN LIGATOR?

The FDA product code for O'REGAN LIGATOR is FHN.

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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

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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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