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FDA 510(k)

TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709

K-Number: K831392 · 1983-07-12

ApplicantTravenol Laboratories, S.A.
Decision Date1983-07-12
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831392. 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 TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709?

TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K831392.

When did TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 receive FDA 510(k) clearance?

TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831392.

Who is the listed applicant for TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709?

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

What is the FDA product code for TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709?

The FDA product code for TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 is GAA.

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Other records listing Travenol Laboratories, S.A. as applicant

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K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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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