Colonoscopic Injection Needle, C-323/C-325

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

510(k) Number

K921800 ↗

FDA Product Code

FBK

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Mill-Rose Harrell Bronchial Brush

  Class II

  FDA 510(k) K944649 Active Cleared 30 Nov 1994

• Stone and Retrieval Basket

  Class II

  FDA 510(k) K792344 Active Cleared 20 Dec 1979

• Esophageal Dilator Set

  Class II

  FDA 510(k) K842679 Active Cleared 2 Oct 1984

• Diathermic Snare (Cresent Type)

  Class II

  FDA 510(k) K792343 Active Cleared 18 Dec 1979

• Thoracentisis Kit

  Class I

  FDA 510(k) K894326 Active Cleared 24 Jul 1989

• Endoscopic Injection Needle

  Class II

  FDA 510(k) K820973 Active Cleared 16 Apr 1982

See all devices from Mill-Rose Laboratory →