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510(k) K020925

CARBODISSECTING ENDOSCOPE by Endo Surgical Devices, Inc. — Product Code DWX

K020925 is an FDA 510(k) premarket notification submitted by Endo Surgical Devices, Inc. for the device "CARBODISSECTING ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on April 29, 2003. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. Endo Surgical Devices, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2003
Date Received
March 21, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Artery, Intraluminal
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

Other clearances by Endo Surgical Devices, Inc.

  • K013680 — CARBODISSECTING ENDOSCOPE (March 4, 2002)

Other clearances for product code DWX

  • K121415 — MOLLRING MULTITASC (September 5, 2012)
  • K032105 — ENDOHELIX ENDARTERECTOMY DEVICE (October 30, 2003)
  • K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICE (February 28, 2001)
  • K950813 — MOLLRING CUTTER (July 25, 1995)
  • K933498 — EXTERNAL VEIN STRIPPER (March 23, 1994)
  • K913803 — INTRALUMINAL ARTERY STRIPPER (April 24, 1992)
  • K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (June 25, 1991)
  • K904944 — TRANSLUMINAL ENDARTERECTOMY DEVICE (December 17, 1990)
  • K895878 — OLYMPUS VALVULOTOME W/DETACHABLE TIP (January 2, 1990)
  • K894496 — OLYMPUS VALVULOTOME W/FIXED TIP (October 12, 1989)

FDA data resources