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FDA 510(k)

Irrigation Tubing with CO2 or Air

K-Number: K193250 · 2020-04-06

ApplicantKeymed (Medical and Industrial Equipment) , Ltd.
Decision Date2020-04-06
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Irrigation Tubing with CO2 or Air is the device name listed in this FDA 510(k) record. The listed applicant is Keymed (Medical and Industrial Equipment) , Ltd.. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K193250. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Irrigation Tubing with CO2 or Air?

Irrigation Tubing with CO2 or Air is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Keymed (Medical and Industrial Equipment) , Ltd.. The 510(k) number is K193250.

When did Irrigation Tubing with CO2 or Air receive FDA 510(k) clearance?

Irrigation Tubing with CO2 or Air received FDA 510(k) clearance on 2020-04-06, under 510(k) number K193250.

Who is the listed applicant for Irrigation Tubing with CO2 or Air?

The FDA 510(k) record lists Keymed (Medical and Industrial Equipment) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Irrigation Tubing with CO2 or Air?

The FDA product code for Irrigation Tubing with CO2 or Air is OCX.

Related Devices (Code: OCX)

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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