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FDA 510(k)

N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE

K-Number: K983218 · 1998-11-06

ApplicantAvid N.I.T., Inc.
Decision Date1998-11-06
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE 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 1998-11-06 under 510(k) number K983218. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE?

N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Avid N.I.T., Inc.. The 510(k) number is K983218.

When did N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE receive FDA 510(k) clearance?

N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE received FDA 510(k) clearance on 1998-11-06, under 510(k) number K983218.

Who is the listed applicant for N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE?

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. AUTOMATIC CUTTING BIOPSY NEEDLE?

The FDA product code for N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE is FCG.

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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 RM2035LK972595ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCERK972554REGANES RADIONUCLIDE SEED MAGAZINEK973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000K973638N.I.T., INC. NEEDLE GUIDING TEMPLATE

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Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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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