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510(k) K093329

SCOPE INTRODUCER MODEL 7400 by N.M. Beale Co., Inc. — Product Code ODC

K093329 is an FDA 510(k) premarket notification submitted by N.M. Beale Co., Inc. for the device "SCOPE INTRODUCER MODEL 7400". The FDA issued a decision of Substantially Equivalent on February 16, 2010. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. N.M. Beale Co., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2010
Date Received
October 26, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

Other clearances by N.M. Beale Co., Inc.

  • K093584 — EZ-MISTER (March 4, 2011)
  • K071579 — PEF TUBE (November 20, 2007)
  • K992178 — BALLOON FOR ULTRASONIC ENDOSCOPES (May 12, 2000)
  • K903834 — N. M. BEALE COMPANY VU-THRU WATER BOTTLE (September 24, 1990)

Other clearances for product code ODC

  • K252933 — DYNE PORT (June 12, 2026)
  • K250145 — Biopsy Port Adapter (October 17, 2025)
  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (July 16, 2025)
  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (March 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (February 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)

FDA data resources