Lavaging Catheters

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

510(k) Number

K822061 ↗

FDA Product Code

OCX

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Retrieval Forceps

  Class II

  FDA 510(k) K820239 Active Cleared 26 Mar 1982

• Percutaneous Endoscopic Gastroscopy

  Class II

  FDA 510(k) K833492 Active Cleared 29 Nov 1983

• Proxima 1 Ph Monitor

  Class I

  FDA 510(k) K841384 Active Cleared 19 Jul 1984

• Papillotomes

  Class II

  FDA 510(k) K820240 Active Cleared 26 Mar 1982

• Pigtail Stents

  Class II

  FDA 510(k) K821819 Active Cleared 20 Aug 1982

• Sterile Cytology Brushes

  Class I

  FDA 510(k) K820259 Active Cleared 5 Mar 1982

See all devices from American Endoscopy, Inc. →

• What are Lavaging Catheters used for?

  Lavaging Catheters are endoscopic irrigation/suction systems used in gastroenterology and urology procedures. They are intended for use in endoscopic irrigation and suction applications, allowing fluid delivery and removal during endoscopic examinations or interventions.

• Who manufactures the Lavaging Catheters and what is their regulatory clearance?

  The Lavaging Catheters are manufactured by American Endoscopy, Inc. They received FDA 510(k) clearance K822061 on July 20, 1982, through the Traditional pathway after being found substantially equivalent to a predicate device.

• What regulatory classification and product code apply to the Lavaging Catheters?

  The Lavaging Catheters are classified as a Class 2 medical device under regulation number 876.1500 with product code OCX. This classification applies to endoscopic irrigation/suction systems used in gastroenterology and urology.