Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

K-Number: K180542 · 2018-08-22

ApplicantBoston Endo Surgical Tech,
Decision Date2018-08-22
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe is a medical device manufactured by Boston Endo Surgical Tech,. It received FDA 510(k) clearance on 2018-08-22 under approval number K180542. 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 NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe?

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe is a medical device that received FDA 510(k) clearance on 2018-08-22. It is manufactured by Boston Endo Surgical Tech,. The 510(k) number is K180542.

When was NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe approved by the FDA?

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe received FDA 510(k) clearance on 2018-08-22, under approval number K180542.

What company makes NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe?

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe is manufactured by Boston Endo Surgical Tech,.

What is the FDA product code for NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe?

The FDA product code for NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe is PDQ.

Related Clinical Trials

NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING

Other Devices by Boston Endo Surgical Tech,

K182662NAV PAK Needle, NIM NAV PAK Needle

Related Devices (Code: PDQ)

K161893Neuromonitoring KitSI-BONE, Inc. K152747DSG Threaded Drill SystemSpineguard S.A. K152942NuVasiveNVM5 SystemNu Vasive, Incorporated K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, 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.

↑