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FDA 510(k)

IMPROVED DISPOSABLE HYPODERMIC NEEDLE

K-Number: K780887 · 1978-06-22

ApplicantPharmaseal Div., Baxter Healthcare Corp.
Decision Date1978-06-22
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPROVED DISPOSABLE HYPODERMIC NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780887. 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 IMPROVED DISPOSABLE HYPODERMIC NEEDLE?

IMPROVED DISPOSABLE HYPODERMIC NEEDLE is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Pharmaseal Div., Baxter Healthcare Corp.. The 510(k) number is K780887.

When did IMPROVED DISPOSABLE HYPODERMIC NEEDLE receive FDA 510(k) clearance?

IMPROVED DISPOSABLE HYPODERMIC NEEDLE received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780887.

Who is the listed applicant for IMPROVED DISPOSABLE HYPODERMIC NEEDLE?

The FDA 510(k) record lists Pharmaseal Div., Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPROVED DISPOSABLE HYPODERMIC NEEDLE?

The FDA product code for IMPROVED DISPOSABLE HYPODERMIC NEEDLE is GAA.

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Other records listing Pharmaseal Div., Baxter Healthcare Corp. as applicant

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.

K792369HYPERALIMENTATION DRESSING TRAYK792141CONTINUOUS FLUSH DEVICEK792019PHADECODE XA INHIBITOR ASSAYK791773VENTILATOR TUBE WITH FILTERK791156AMIPAQUE MYELOGRAM TRAYK790896TWO-WAY ANESTHESIA FILTER

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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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