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FDA 510(k)

INTRA-ARTICULAR C02 INSUFFLATOR

K-Number: K823499 · 1983-01-28

ApplicantSurgical Instrument Repair Service Co.
Decision Date1983-01-28
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTRA-ARTICULAR C02 INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Repair Service Co.. It received FDA 510(k) clearance on 1983-01-28 under 510(k) number K823499. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA-ARTICULAR C02 INSUFFLATOR?

INTRA-ARTICULAR C02 INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1983-01-28. The listed applicant is Surgical Instrument Repair Service Co.. The 510(k) number is K823499.

When did INTRA-ARTICULAR C02 INSUFFLATOR receive FDA 510(k) clearance?

INTRA-ARTICULAR C02 INSUFFLATOR received FDA 510(k) clearance on 1983-01-28, under 510(k) number K823499.

Who is the listed applicant for INTRA-ARTICULAR C02 INSUFFLATOR?

The FDA 510(k) record lists Surgical Instrument Repair Service Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRA-ARTICULAR C02 INSUFFLATOR?

The FDA product code for INTRA-ARTICULAR C02 INSUFFLATOR is HRX.

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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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