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FDA 510(k)

ASPIRATION/INJECTION NEEDLE

K-Number: K913992 · 1991-10-30

ApplicantNorthgate Technologies, Inc.
Decision Date1991-10-30
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASPIRATION/INJECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 1991-10-30 under 510(k) number K913992. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPIRATION/INJECTION NEEDLE?

ASPIRATION/INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K913992.

When did ASPIRATION/INJECTION NEEDLE receive FDA 510(k) clearance?

ASPIRATION/INJECTION NEEDLE received FDA 510(k) clearance on 1991-10-30, under 510(k) number K913992.

Who is the listed applicant for ASPIRATION/INJECTION NEEDLE?

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

What is the FDA product code for ASPIRATION/INJECTION NEEDLE?

The FDA product code for ASPIRATION/INJECTION NEEDLE is GAA.

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Other records listing Northgate Technologies, Inc. as applicant

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Related Devices (Code: GAA)

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.

K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, Inc.

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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