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

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 the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare Limited. It received FDA 510(k) clearance on 2021-02-19 under 510(k) 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. The listed applicant is Huntleigh Healthcare Limited. The 510(k) number is K201425.

When did Disposable Intraoperative Probe (DIOP8) receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Intraoperative Probe (DIOP8)?

The FDA 510(k) record lists Huntleigh Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Huntleigh Healthcare Limited 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.

K250777Sonicaid Team3K241368Sonicaid Team3K211200WoundExpressK200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumK183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesK152228Hydroven 12, Hydroven 12 Garments

View all 7 devices →

Related Devices (Code: ITX)

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.

K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

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.

↑