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)

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

K-Number: K231666 · 2023-12-13

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2023-12-13
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-12-13 under approval number K231666. 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 Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)?

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K231666.

When was Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) approved by the FDA?

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) received FDA 510(k) clearance on 2023-12-13, under approval number K231666.

What company makes Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)?

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) is manufactured by FUJIFILM Healthcare Americas Corporation.

What is the FDA product code for Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)?

The FDA product code for Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) is ITX.

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 NCT01931579 Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses. COMPLETED

Other Devices by FUJIFILM Healthcare Americas Corporation

K231941ARIETTA x10 K231574Scenaria View 4.2 K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214C K233629APERTO Lucent MRI System

View all 12 devices →

Related Devices (Code: ITX)

K152126UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc. K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc.

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.

↑