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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 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 2018-08-22 under 510(k) 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. The listed applicant is Boston Endo Surgical Tech,. The 510(k) number is K180542.

When did NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe receive FDA 510(k) clearance?

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

Who is the listed applicant for NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe?

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 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.

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.

K182662NAV PAK Needle, NIM NAV PAK Needle

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.

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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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