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FDA 510(k)

TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK

K-Number: K864830 · 1987-01-12

ApplicantProfessional Instruments Co.
Decision Date1987-01-12
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Professional Instruments Co.. It received FDA 510(k) clearance on 1987-01-12 under 510(k) number K864830. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK?

TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK is a medical device that received FDA 510(k) clearance on 1987-01-12. The listed applicant is Professional Instruments Co.. The 510(k) number is K864830.

When did TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK receive FDA 510(k) clearance?

TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK received FDA 510(k) clearance on 1987-01-12, under 510(k) number K864830.

Who is the listed applicant for TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK?

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

What is the FDA product code for TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK?

The FDA product code for TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK is BXN.

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 Professional Instruments Co. 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.

K864829MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULATK810206DUAL TYPE ELECTRODE

Related Devices (Code: BXN)

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.

K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.K162086MultiStim ECOPAJUNK GmbH MedizintechnologieK153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd.K121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINSunmed, LLCK111985MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.K110118STIMTRODE SINGLE USE NERVE STIMULATORXavant Technology (Pty), Ltd.

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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