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FDA 510(k)

REGANES SPINAL NEEDLE (VARIOUS)

K-Number: K971645 · 1997-08-01

ApplicantAvid N.I.T., Inc.
Decision Date1997-08-01
Product CodeMIA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REGANES SPINAL NEEDLE (VARIOUS) is the device name listed in this FDA 510(k) record. The listed applicant is Avid N.I.T., Inc.. It received FDA 510(k) clearance on 1997-08-01 under 510(k) number K971645. The device is classified under product code MIA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGANES SPINAL NEEDLE (VARIOUS)?

REGANES SPINAL NEEDLE (VARIOUS) is a medical device that received FDA 510(k) clearance on 1997-08-01. The listed applicant is Avid N.I.T., Inc.. The 510(k) number is K971645.

When did REGANES SPINAL NEEDLE (VARIOUS) receive FDA 510(k) clearance?

REGANES SPINAL NEEDLE (VARIOUS) received FDA 510(k) clearance on 1997-08-01, under 510(k) number K971645.

Who is the listed applicant for REGANES SPINAL NEEDLE (VARIOUS)?

The FDA 510(k) record lists Avid N.I.T., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGANES SPINAL NEEDLE (VARIOUS)?

The FDA product code for REGANES SPINAL NEEDLE (VARIOUS) is MIA.

Related Clinical Trials

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Other records listing Avid N.I.T., Inc. 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.

K014246AVID-NIT NERVE STIMULATION NEEDLESK013231AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035LK983218N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLEK972595ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCERK972554REGANES RADIONUCLIDE SEED MAGAZINEK973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000

View all 9 devices →

Related Devices (Code: MIA)

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.

K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectorsSmiths Medical Asd, Inc.K051860FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837Epimed International, Inc.K983858SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLESSims Portex, Inc.K982269CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GAAllegiance Healthcare Corp.K970997NEO-CARE LUMBER PUNCTURE KITKlein-Baker Medical, Inc.K961324GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLESGlobal Medical Prods, 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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