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FDA 510(k)

ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE

K-Number: K934398 · 1994-02-14

ApplicantTransamerican Technologies Intl.
Decision Date1994-02-14
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Transamerican Technologies Intl.. It received FDA 510(k) clearance on 1994-02-14 under 510(k) number K934398. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE?

ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 1994-02-14. The listed applicant is Transamerican Technologies Intl.. The 510(k) number is K934398.

When did ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE receive FDA 510(k) clearance?

ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE received FDA 510(k) clearance on 1994-02-14, under 510(k) number K934398.

Who is the listed applicant for ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE?

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

What is the FDA product code for ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE?

The FDA product code for ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE is GCJ.

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Other records listing Transamerican Technologies Intl. 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.

K971677ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORDK963193ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39K864378CO2 LASER MICROMANIPULATOR

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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