510(k) K833491

ENDO BITE BLOCK by American Endoscopy, Inc. — Product Code KTI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 25, 1984
Date Received: October 7, 1983
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bronchoscope Accessory
Device Class: Class II
Regulation Number: 874.4680
Review Panel: EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by American Endoscopy, Inc.

K853274 — AMERICAN DILATATION SYSTEM (October 17, 1985)
K841384 — PROXIMA 1 PH MONITOR (July 19, 1984)
K840818 — BIOPSY FORCEPS (April 13, 1984)
K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
K833492 — PERCUTANEOUS ENDOSCOPIC GASTROSCOPY (November 29, 1983)
K832458 — AUTOMATIC ENDOSCOPE (October 20, 1983)
K821818 — RETRIEVAL BALLOONS (September 24, 1982)
K821819 — PIGTAIL STENTS (August 20, 1982)
K822062 — BALL TIP COAGULATING ELECTRODES (August 19, 1982)
K821817 — PIGTAIL NASAL CATHETERS (August 10, 1982)

Other clearances for product code KTI

K254040 — LungFlow Basket Catheter (March 12, 2026)
K251402 — LIA-1 Catheter (542-1) (December 19, 2025)
K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (October 8, 2025)
K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA (July 29, 2025)
K250263 — Disposable Grasping Forceps FG-52D/FG-54D (March 31, 2025)
K241679 — Disposable Cytology Brush (AF series) (March 4, 2025)
K231818 — METIC- Airway Balloon Catheter (November 15, 2023)
K230778 — EndoCore (September 25, 2023)
K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (May 11, 2023)
K222187 — Multistage Balloon Dilatation Catheter (March 1, 2023)