FDA 510(k)

BIOPSY NEEDLE GUIDE KIT, STERILE

K-Number: K871503 · 1987-07-10

Decision Date1987-07-10

Product CodeFZX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BIOPSY NEEDLE GUIDE KIT, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Amedic USA. It received FDA 510(k) clearance on 1987-07-10 under 510(k) number K871503. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY NEEDLE GUIDE KIT, STERILE?

BIOPSY NEEDLE GUIDE KIT, STERILE is a medical device that received FDA 510(k) clearance on 1987-07-10. The listed applicant is Amedic USA. The 510(k) number is K871503.

When did BIOPSY NEEDLE GUIDE KIT, STERILE receive FDA 510(k) clearance?

BIOPSY NEEDLE GUIDE KIT, STERILE received FDA 510(k) clearance on 1987-07-10, under 510(k) number K871503.

Who is the listed applicant for BIOPSY NEEDLE GUIDE KIT, STERILE?

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

What is the FDA product code for BIOPSY NEEDLE GUIDE KIT, STERILE?

The FDA product code for BIOPSY NEEDLE GUIDE KIT, STERILE is FZX.

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 Amedic USA as applicant

K897120EQUIP COVERS, STERILE K892070GENERAL IVT NEEDLE GUIDE KIT, STERILE K892071GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE K892069EXTENDED COVERS, STERILE K892068TRT (ACUSON) NEEDLE GUIDE KIT, STERILE K871467BIOPSY NEEDLE GUIDE KIT, STERILE

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Related Devices (Code: FZX)

K914715PARALLELING GUIDESImplant Corp. of America K871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.K842698BRITISH SPINAL FUSION SETDowns Surgical , Ltd.

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.