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FDA 510(k)

N.I.T., INC. NEEDLE GUIDING TEMPLATE

K-Number: K973638 · 1997-12-23

ApplicantAvid N.I.T., Inc.
Decision Date1997-12-23
Product CodeIWJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

N.I.T., INC. NEEDLE GUIDING TEMPLATE 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 1997-12-23 under 510(k) number K973638. The device is classified under product code IWJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N.I.T., INC. NEEDLE GUIDING TEMPLATE?

N.I.T., INC. NEEDLE GUIDING TEMPLATE is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Avid N.I.T., Inc.. The 510(k) number is K973638.

When did N.I.T., INC. NEEDLE GUIDING TEMPLATE receive FDA 510(k) clearance?

N.I.T., INC. NEEDLE GUIDING TEMPLATE received FDA 510(k) clearance on 1997-12-23, under 510(k) number K973638.

Who is the listed applicant for N.I.T., INC. NEEDLE GUIDING TEMPLATE?

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 N.I.T., INC. NEEDLE GUIDING TEMPLATE?

The FDA product code for N.I.T., INC. NEEDLE GUIDING TEMPLATE is IWJ.

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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

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Related Devices (Code: IWJ)

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.

K010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMImagyn Medical Technologies, Inc.K980997PGK DEVICE (MODIFIED)Pgk, Inc.K972554REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLCK973786NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDENw Radiation Therapy Products

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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