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FDA 510(k)

THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES

K-Number: K103647 · 2011-03-01

ApplicantThd Spa
Decision Date2011-03-01
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Thd Spa. It received FDA 510(k) clearance on 2011-03-01 under 510(k) number K103647. 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 ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES?

THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES is a medical device that received FDA 510(k) clearance on 2011-03-01. The listed applicant is Thd Spa. The 510(k) number is K103647.

When did THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES receive FDA 510(k) clearance?

THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES received FDA 510(k) clearance on 2011-03-01, under 510(k) number K103647.

Who is the listed applicant for THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES?

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 ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES?

The FDA product code for THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES 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

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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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