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FDA 510(k)

HYPODERMIC NEEDLE AND STYLET

K-Number: K854579 · 1985-12-17

ApplicantBerkley and Co.
Decision Date1985-12-17
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYPODERMIC NEEDLE AND STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Berkley and Co.. It received FDA 510(k) clearance on 1985-12-17 under 510(k) number K854579. 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 HYPODERMIC NEEDLE AND STYLET?

HYPODERMIC NEEDLE AND STYLET is a medical device that received FDA 510(k) clearance on 1985-12-17. The listed applicant is Berkley and Co.. The 510(k) number is K854579.

When did HYPODERMIC NEEDLE AND STYLET receive FDA 510(k) clearance?

HYPODERMIC NEEDLE AND STYLET received FDA 510(k) clearance on 1985-12-17, under 510(k) number K854579.

Who is the listed applicant for HYPODERMIC NEEDLE AND STYLET?

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

What is the FDA product code for HYPODERMIC NEEDLE AND STYLET?

The FDA product code for HYPODERMIC NEEDLE AND STYLET is GAA.

Related Clinical Trials

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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Other records listing Berkley and Co. 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.

K843171FILAFEX TM, ESTHETIC ORTHODONTIC WIREK833788FILAFEX ESTHETIC ORTHODINIC WIRE

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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