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FDA 510(k)

Disposable Intraoperative Probe (DIOP8)

K-Number: K201425 · 2021-02-19

ApplicantHuntleigh Healthcare Limited
Decision Date2021-02-19
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Disposable Intraoperative Probe (DIOP8) is a medical device manufactured by Huntleigh Healthcare Limited. It received FDA 510(k) clearance on 2021-02-19 under approval number K201425. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Intraoperative Probe (DIOP8)?

Disposable Intraoperative Probe (DIOP8) is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Huntleigh Healthcare Limited. The 510(k) number is K201425.

When was Disposable Intraoperative Probe (DIOP8) approved by the FDA?

Disposable Intraoperative Probe (DIOP8) received FDA 510(k) clearance on 2021-02-19, under approval number K201425.

What company makes Disposable Intraoperative Probe (DIOP8)?

Disposable Intraoperative Probe (DIOP8) is manufactured by Huntleigh Healthcare Limited.

What is the FDA product code for Disposable Intraoperative Probe (DIOP8)?

The FDA product code for Disposable Intraoperative Probe (DIOP8) is ITX.

Related Clinical Trials

NCT06039085 Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment RECRUITING NCT07054411 Hemoglobin Monitoring in Scoliosis Surgery COMPLETED

Other Devices by Huntleigh Healthcare Limited

K200975Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum

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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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