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FDA 510(k)

VALVED SURGICAL ASPIRATORS

K-Number: K813029 · 1981-12-14

ApplicantImedix
Decision Date1981-12-14
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VALVED SURGICAL ASPIRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Imedix. It received FDA 510(k) clearance on 1981-12-14 under 510(k) number K813029. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALVED SURGICAL ASPIRATORS?

VALVED SURGICAL ASPIRATORS is a medical device that received FDA 510(k) clearance on 1981-12-14. The listed applicant is Imedix. The 510(k) number is K813029.

When did VALVED SURGICAL ASPIRATORS receive FDA 510(k) clearance?

VALVED SURGICAL ASPIRATORS received FDA 510(k) clearance on 1981-12-14, under 510(k) number K813029.

Who is the listed applicant for VALVED SURGICAL ASPIRATORS?

The FDA 510(k) record lists Imedix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALVED SURGICAL ASPIRATORS?

The FDA product code for VALVED SURGICAL ASPIRATORS is GCX.

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Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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