PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K030854 ↗

FDA Product Code

FCX

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Enterocysis Tube W/Guide Wire & Connect

  Class II

  FDA 510(k) K840752 Active Cleared 2 May 1984

• E-Z-Em(R) Lufkin Biopsy Needles

  Class I

  FDA 510(k) K882601 Active Cleared 25 Jul 1988

• E-Z-Em Single Stick Puncture/Drainage

  Unclassified

  FDA 510(k) K842121 Active Cleared 1 Oct 1984

• Winged Infusion Set

  Class II

  FDA 510(k) K885264 Active Cleared 31 Jan 1989

• Bronchial Cytology Brush

  Not classified

  FDA 510(k) K853667 Active Cleared 18 Dec 1985

• Disposable Angiography Needles

  Class II

  FDA 510(k) K890209 Active Cleared 19 May 1989

See all devices from E-Z-Em, Inc. →