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FDA 510(k)

THD BANDY

K-Number: K093497 · 2010-07-15

ApplicantThd Spa
Decision Date2010-07-15
Product CodeFHN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THD BANDY is the device name listed in this FDA 510(k) record. The listed applicant is Thd Spa. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K093497. 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 THD BANDY?

THD BANDY is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Thd Spa. The 510(k) number is K093497.

When did THD BANDY receive FDA 510(k) clearance?

THD BANDY received FDA 510(k) clearance on 2010-07-15, under 510(k) number K093497.

Who is the listed applicant for THD BANDY?

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

What is the FDA product code for THD BANDY?

The FDA product code for THD BANDY is FHN.

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Other records listing Thd Spa 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.

K211623THD Procto Software SystemK193512THD Procto Software SystemK180135THD Anopress with THD SensyProbeK161785THD ANOPRESSK133687THD N-ANO ANOSCOPEK121135THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE

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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 MedicalK091519HAEMOBAND MULTI-LIGATORHaemoband Surgical, Ltd.K070881LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660Sapimed S.P.A.K020824SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238Boston Scientific Corp

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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