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FDA 510(k)

ACCU-CORE DISPOSABLE BIOPSY NEEDLE

K-Number: K801457 · 1980-07-14

ApplicantMedline Industries, Inc.
Decision Date1980-07-14
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCU-CORE DISPOSABLE BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801457. 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 ACCU-CORE DISPOSABLE BIOPSY NEEDLE?

ACCU-CORE DISPOSABLE BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Medline Industries, Inc.. The 510(k) number is K801457.

When did ACCU-CORE DISPOSABLE BIOPSY NEEDLE receive FDA 510(k) clearance?

ACCU-CORE DISPOSABLE BIOPSY NEEDLE received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801457.

Who is the listed applicant for ACCU-CORE DISPOSABLE BIOPSY NEEDLE?

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

What is the FDA product code for ACCU-CORE DISPOSABLE BIOPSY NEEDLE?

The FDA product code for ACCU-CORE DISPOSABLE BIOPSY NEEDLE is GAA.

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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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