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FDA 510(k)

AIR ASPIRATOR NEEDLE

K-Number: K801393 · 1980-06-30

ApplicantTexas Medical Products, Inc.
Decision Date1980-06-30
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AIR ASPIRATOR NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medical Products, Inc.. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K801393. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR ASPIRATOR NEEDLE?

AIR ASPIRATOR NEEDLE is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is Texas Medical Products, Inc.. The 510(k) number is K801393.

When did AIR ASPIRATOR NEEDLE receive FDA 510(k) clearance?

AIR ASPIRATOR NEEDLE received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801393.

Who is the listed applicant for AIR ASPIRATOR NEEDLE?

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

What is the FDA product code for AIR ASPIRATOR NEEDLE?

The FDA product code for AIR ASPIRATOR NEEDLE is DWS.

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Other records listing Texas Medical Products, Inc. as applicant

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Related Devices (Code: DWS)

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

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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