510(k) K840722

ENTEROSCOPE by Trimedyne, Inc. — Product Code FDA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 7, 1984
Date Received: February 17, 1984
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Enteroscope And Accessories
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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 Trimedyne, Inc.

K053457 — VAPORMAX II (December 21, 2005)
K050412 — VAPORMAX (March 14, 2005)
K043012 — OMNIPULSE MINI, MODEL 2120 (November 17, 2004)
K041660 — TRIMEDYNE HOLMIUM LASER SYSTEMS (September 8, 2004)
K022655 — TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH (November 7, 2002)
K013974 — RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A (September 23, 2002)
K002308 — OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, (December 20, 2000)
K001676 — OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, (November 2, 2000)
K992574 — OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MO (October 29, 1999)
K992230 — OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP (July 12, 1999)

Other clearances for product code FDA

K251204 — FUJIFILM Stiffening Wire Device (SW-2000) (September 26, 2025)
K233321 — Double Balloon Endoscope EN-840T, Over-tube TS-1214C (June 13, 2024)
K231323 — Ancora-SB (August 31, 2023)
K223295 — Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (January 11, 2023)
K213195 — Balloon BS-3 (October 29, 2021)
K191330 — Arc Enterocuff (January 31, 2020)
K183032 — FUJIFILM Double Balloon Endoscope EI580BT (June 24, 2019)
K183683 — FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 (February 27, 2019)
K143556 — Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (August 20, 2015)
K071254 — SMALL INTESTINAL VIDEOSCOPE SYSTEM (March 25, 2008)