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FDA 510(k)

INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX

K-Number: K983200 · 1998-12-11

ApplicantXimed/Prosure/Injectx
Decision Date1998-12-11
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Ximed/Prosure/Injectx. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K983200. 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 INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX?

INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Ximed/Prosure/Injectx. The 510(k) number is K983200.

When did INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX receive FDA 510(k) clearance?

INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX received FDA 510(k) clearance on 1998-12-11, under 510(k) number K983200.

Who is the listed applicant for INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX?

The FDA 510(k) record lists Ximed/Prosure/Injectx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX?

The FDA product code for INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX is GAA.

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Other records listing Ximed/Prosure/Injectx 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.

K002269ELECTROSURGICAL PROBES AND DEVICES-GELTXK994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESK983765INJECTION NEEDLE PROBE/DEVICE-TUNISK981256ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODEK974484ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODEK974637ELECTRODES/PROBES/DEVICES

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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/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, Inc.K962425BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)Radi Medical Systems AB

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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