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510(k) K942068

AMERICAN CATHETER SPHINCTEROTOME by Intl. Medical, Inc. — Product Code KNS

K942068 is an FDA 510(k) premarket notification submitted by Intl. Medical, Inc. for the device "AMERICAN CATHETER SPHINCTEROTOME". The FDA issued a decision of Substantially Equivalent on June 24, 1994. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Intl. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1994
Date Received
April 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Intl. Medical, Inc.

  • K970507 — PEAK FLOW METER (June 13, 1997)
  • K943078 — HOT BIOPSY FORCEPS (November 14, 1994)
  • K940370 — AMERICAN CATHETER E.R.C.P. CANNULA (August 17, 1994)
  • K940335 — AMERICAN CATHETER POLY-SNARE (July 21, 1994)
  • K930410 — DURHAM; LUER LOCK EXTENSION SET (September 3, 1993)
  • K930406 — DURHAM; MIN BORE LUER LOCK EXTENSION SET (September 3, 1993)
  • K923200 — AMCATH DISPOSABLE CYTOLOGY BRUSH (December 7, 1992)
  • K915142 — AMCATH DISPOSABLE BIOPSY FORCEPS (January 10, 1992)
  • K912927 — AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE (September 19, 1991)
  • K912605 — AMCATH DISPOSABLE MICRO SCISSORS (July 11, 1991)

Other clearances for product code KNS

  • K260962 — Sphincterotome (May 21, 2026)
  • K252388 — Vanquish Water Vapor Ablation Device (November 26, 2025)
  • K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
  • K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
  • K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
  • K251104 — SureTome™ SW Sphincterotome with DomeTip (September 29, 2025)
  • K251226 — Aqua Medical RF Vapor Ablation System (August 8, 2025)
  • K250584 — Rezum System (June 11, 2025)
  • K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) (June 6, 2025)
  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)

FDA data resources