Endo Bite Block

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

510(k) Number

K833491 ↗

FDA Product Code

KTI

Device Class

Class II

Regulation

21 CFR Part 874.4680

Advisory Committee

Ear, Nose, Throat

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

• Lavaging Catheters

  Class II

  FDA 510(k) K822061 Active Cleared 20 Jul 1982

• Pigtail Stents

  Class II

  FDA 510(k) K821819 Active Cleared 20 Aug 1982

See all devices from American Endoscopy, Inc. →

• What is the purpose of the Endo Bite Block?

  The Endo Bite Block is designed for use during upper endoscopic procedures to provide comfort and protection by keeping the lower jaw forward and maintaining an open airway during examinations.

• How is the Endo Bite Block supplied?

  The Endo Bite Block is supplied as a single-use disposable item in various sizes and designs, with or without retaining straps, ensuring hygiene and convenience for each procedure.

• What is the regulatory classification of the Endo Bite Block?

  The Endo Bite Block is classified as a Class II medical device and received FDA 510(k) clearance with the product code KTI under regulation 874.4680, indicating it meets specific safety and effectiveness requirements.

• Can the Endo Bite Block be reused?

  No, the Endo Bite Block is designed as a single-use disposable item to prevent cross-contamination and ensure patient safety during endoscopic procedures.