Prepacell Thin Needle Aspiration Tray

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

510(k) Number

K833719 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Prepacell-Bone Marrow Sampler

  Class II

  FDA 510(k) K791660 Active Cleared 12 Sep 1979

• Percutaneous Aspiration Biopsy Tray

  Not classified

  FDA 510(k) K843885 Active Cleared 19 Dec 1984

• Prepacell-Sterile-Bone Marrow Aspir

  Class I

  FDA 510(k) K833438 Active Cleared 9 Feb 1984

• Chemonucleolysis/Discography Tray

  Class II

  FDA 510(k) K840334 Active Cleared 13 Apr 1984

• Ultrasound Probe Covers-Sterile

  Class II

  FDA 510(k) K842591 Active Cleared 23 Jul 1984

• Transthoracic/Transabdominal-Tray

  Class I

  FDA 510(k) K833720 Active Cleared 30 May 1984

See all devices from Applied Medical Devices, Inc. →

• What is the Prepacell Thin Needle Aspiration Tray used for?

  The Prepacell Thin Needle Aspiration Tray is a catheter used for aspiration procedures in gastroenterology and urology settings, as indicated by its classification under FDA regulation 876.5130 and its medical specialty description.

• Is the Prepacell Thin Needle Aspiration Tray sterile or non-sterile when supplied?

  The device is supplied non-sterile, as explicitly stated in the device description, and is intended for single-use only.

• Can the Prepacell Thin Needle Aspiration Tray be reused after a procedure?

  No, the device is intended for single-use only, as specified in the description, meaning it should not be reprocessed or reused after initial use.

• What regulatory pathway was used for the Prepacell Thin Needle Aspiration Tray?

  The device received FDA 510(k) clearance (K833719) on January 25, 1984, and was found substantially equivalent to a predicate device through the traditional 510(k) process.

• What class of medical device is the Prepacell Thin Needle Aspiration Tray?

  The device is classified as a Class II medical device under FDA regulation 876.5130, as stated in the device description and confirmed by the openfda field indicating device_class=2.