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FDA 510(k)

STERILE, DISPOSABLE NEEDLE

K-Number: K852817 · 1985-07-26

ApplicantFabersanitas, S.A.
Decision Date1985-07-26
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE, DISPOSABLE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Fabersanitas, S.A.. It received FDA 510(k) clearance on 1985-07-26 under 510(k) number K852817. 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 STERILE, DISPOSABLE NEEDLE?

STERILE, DISPOSABLE NEEDLE is a medical device that received FDA 510(k) clearance on 1985-07-26. The listed applicant is Fabersanitas, S.A.. The 510(k) number is K852817.

When did STERILE, DISPOSABLE NEEDLE receive FDA 510(k) clearance?

STERILE, DISPOSABLE NEEDLE received FDA 510(k) clearance on 1985-07-26, under 510(k) number K852817.

Who is the listed applicant for STERILE, DISPOSABLE NEEDLE?

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

What is the FDA product code for STERILE, DISPOSABLE NEEDLE?

The FDA product code for STERILE, DISPOSABLE NEEDLE 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 Fabersanitas, S.A. 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.

K852819STERILE DISPOSABLE SYRINGE(3 PIECES)K852818STERILE DISPOSABLE SYRINGES(2 PIECES)

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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