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FDA 510(k)

LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660

K-Number: K070881 · 2007-09-26

ApplicantSapimed S.P.A.
Decision Date2007-09-26
Product CodeFHN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 is the device name listed in this FDA 510(k) record. The listed applicant is Sapimed S.P.A.. It received FDA 510(k) clearance on 2007-09-26 under 510(k) number K070881. 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 LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660?

LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 is a medical device that received FDA 510(k) clearance on 2007-09-26. The listed applicant is Sapimed S.P.A.. The 510(k) number is K070881.

When did LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 receive FDA 510(k) clearance?

LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 received FDA 510(k) clearance on 2007-09-26, under 510(k) number K070881.

Who is the listed applicant for LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660?

The FDA 510(k) record lists Sapimed S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660?

The FDA product code for LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 is FHN.

Related Clinical Trials

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.

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Other records listing Sapimed S.P.A. 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.

K070913SELF-LIGHT DISPOSABLE ANOSCOPEK070915SAPIMED DISPOSABLE SIGMOIDOSCOPE

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.K020824SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238Boston Scientific Corp

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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