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FDA 510(k)

TOUCH FOCUS 200MM DEFOCUSING HANDPIECE

K-Number: K945178 · 1995-02-24

ApplicantPlc Medical Systems, Inc.
Decision Date1995-02-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOUCH FOCUS 200MM DEFOCUSING HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Plc Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K945178. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOUCH FOCUS 200MM DEFOCUSING HANDPIECE?

TOUCH FOCUS 200MM DEFOCUSING HANDPIECE is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Plc Medical Systems, Inc.. The 510(k) number is K945178.

When did TOUCH FOCUS 200MM DEFOCUSING HANDPIECE receive FDA 510(k) clearance?

TOUCH FOCUS 200MM DEFOCUSING HANDPIECE received FDA 510(k) clearance on 1995-02-24, under 510(k) number K945178.

Who is the listed applicant for TOUCH FOCUS 200MM DEFOCUSING HANDPIECE?

The FDA 510(k) record lists Plc Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOUCH FOCUS 200MM DEFOCUSING HANDPIECE?

The FDA product code for TOUCH FOCUS 200MM DEFOCUSING HANDPIECE is GEX. This falls under the Gastroenterology category.

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 Plc Medical Systems, Inc. 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.

K945228125MM HANDPIECEK95050550MM HANDPIECE

Related Devices (Code: GEX)

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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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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