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FDA 510(k)

NAV PAK Needle, NIM NAV PAK Needle

K-Number: K182662 · 2019-04-10

ApplicantBoston Endo Surgical Tech,
Decision Date2019-04-10
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NAV PAK Needle, NIM NAV PAK Needle is the device name listed in this FDA 510(k) record. The listed applicant is Boston Endo Surgical Tech,. It received FDA 510(k) clearance on 2019-04-10 under 510(k) number K182662. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAV PAK Needle, NIM NAV PAK Needle?

NAV PAK Needle, NIM NAV PAK Needle is a medical device that received FDA 510(k) clearance on 2019-04-10. The listed applicant is Boston Endo Surgical Tech,. The 510(k) number is K182662.

When did NAV PAK Needle, NIM NAV PAK Needle receive FDA 510(k) clearance?

NAV PAK Needle, NIM NAV PAK Needle received FDA 510(k) clearance on 2019-04-10, under 510(k) number K182662.

Who is the listed applicant for NAV PAK Needle, NIM NAV PAK Needle?

The FDA 510(k) record lists Boston Endo Surgical Tech, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAV PAK Needle, NIM NAV PAK Needle?

The FDA product code for NAV PAK Needle, NIM NAV PAK Needle is PDQ.

Other records listing Boston Endo Surgical Tech, 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.

K180542NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

Related Devices (Code: PDQ)

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.

K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)NeuralytixK253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)Tedan Surgical InnovationsK243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLCK223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARLK221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.K220160PediGuard ThreadedSpineguard S.A.

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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