Olympus NA-10J-1 Aspiration Needle

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970563 ↗

FDA Product Code

FCG

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 3D Surgical Endoscopy System for General Surgery

  Class II

  FDA 510(k) K943307 Active Cleared 20 Dec 1995

• Olympus Fg-45/46-1 Grasping Forceps

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  FDA 510(k) K955049 Active Cleared 15 Dec 1995

• Olympus Unsaturated Iron Binding Capacity Reagent

  Class I

  FDA 510(k) K955139 Active Cleared 12 Feb 1996

• Olympus Fb Series Biopsy Forceps

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• Olympus Fd-5 Hot Biopsy Forceps

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  FDA 510(k) K951445 Active Cleared 3 May 1995

• Olympus Biopsy Forceps Model Fb-44

  Class II

  FDA 510(k) K950786 Active Cleared 6 Mar 1995

See all devices from Olympus America, Inc. →

• What is the Olympus NA-10J-1 Aspiration Needle used for?

  The Olympus NA-10J-1 Aspiration Needle is a biopsy needle designed for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract. It is specifically intended for tissue sampling under endoscopic ultrasound guidance to evaluate lesions such as pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes.

• How is the Olympus NA-10J-1 Aspiration Needle supplied?

  The Olympus NA-10J-1 Aspiration Needle is supplied sterile and must be used in accordance with standard sterile technique. It is a single-use device and is not intended for reuse or resterilization.

• Is the Olympus NA-10J-1 Aspiration Needle single-use or reusable?

  The Olympus NA-10J-1 Aspiration Needle is a single-use device. It is not intended for reuse or resterilization, and must be used in accordance with standard sterile technique to ensure patient safety and device integrity.

• What ultrasound gastroscope is the Olympus NA-10J-1 Aspiration Needle designed for?

  The Olympus NA-10J-1 Aspiration Needle is specifically intended for use with the Olympus GF-UM30P ultrasound gastroscope to perform tissue sampling under endoscopic ultrasound guidance.

• How should the Olympus NA-10J-1 Aspiration Needle be stored?

  The Olympus NA-10J-1 Aspiration Needle should be stored in accordance with manufacturer recommendations to maintain sterility and integrity prior to use. Storage conditions should follow standard sterile technique and manufacturer guidelines to ensure the device remains in a ready-to-use condition.