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FDA 510(k)

THD DISPOSABLE ANOSCOPE/PROCTOSCOPE

K-Number: K080132 · 2008-04-09

ApplicantThd Spa
Decision Date2008-04-09
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THD DISPOSABLE ANOSCOPE/PROCTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Thd Spa. It received FDA 510(k) clearance on 2008-04-09 under 510(k) number K080132. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THD DISPOSABLE ANOSCOPE/PROCTOSCOPE?

THD DISPOSABLE ANOSCOPE/PROCTOSCOPE is a medical device that received FDA 510(k) clearance on 2008-04-09. The listed applicant is Thd Spa. The 510(k) number is K080132.

When did THD DISPOSABLE ANOSCOPE/PROCTOSCOPE receive FDA 510(k) clearance?

THD DISPOSABLE ANOSCOPE/PROCTOSCOPE received FDA 510(k) clearance on 2008-04-09, under 510(k) number K080132.

Who is the listed applicant for THD DISPOSABLE ANOSCOPE/PROCTOSCOPE?

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 DISPOSABLE ANOSCOPE/PROCTOSCOPE?

The FDA product code for THD DISPOSABLE ANOSCOPE/PROCTOSCOPE is FER.

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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

View all 12 devices →

Related Devices (Code: FER)

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.

K250645SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)Haemoband Surgical, Ltd.K242668Gastro Concepts Air AssistGastro Concepts, LLCK230439WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd.K200021Applied Medical AnoscopeApplied Medical ResourcesK171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.K133687THD N-ANO ANOSCOPEThd Spa

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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