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FDA 510(k)

SPINAL NEEDLES & ACCESSORY

K-Number: K834164 · 1983-12-13

ApplicantElfa Trading Co.
Decision Date1983-12-13
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPINAL NEEDLES & ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Elfa Trading Co.. It received FDA 510(k) clearance on 1983-12-13 under 510(k) number K834164. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL NEEDLES & ACCESSORY?

SPINAL NEEDLES & ACCESSORY is a medical device that received FDA 510(k) clearance on 1983-12-13. The listed applicant is Elfa Trading Co.. The 510(k) number is K834164.

When did SPINAL NEEDLES & ACCESSORY receive FDA 510(k) clearance?

SPINAL NEEDLES & ACCESSORY received FDA 510(k) clearance on 1983-12-13, under 510(k) number K834164.

Who is the listed applicant for SPINAL NEEDLES & ACCESSORY?

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

What is the FDA product code for SPINAL NEEDLES & ACCESSORY?

The FDA product code for SPINAL NEEDLES & ACCESSORY is FPK.

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 Elfa Trading 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.

K834165SYRINGE

Related Devices (Code: FPK)

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.

K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic MinimedK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, 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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