Carbodissecting Endoscope
FDA 510(k) K020925 · Endo Surgical Devices, Inc.
510(k) numberK020925
Submission
- Device name
- Carbodissecting Endoscope
- Applicant
- Endo Surgical Devices, Inc.
Hopkonton, MA, US - Received
- March 21, 2002
- Decision date
- April 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWX – Stripper, Artery, Intraluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
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| K121415 | Mollring MultitascDWX · Traditional | LeMaitre Vascular, Inc. | 09/05/2012SE |
| K032105 | Endohelix Endarterectomy DeviceDWX · Traditional | Endarx, Inc. | 10/30/2003SE |
| K003719 | Vascular Architects Periscope DeviceDWX · Traditional | Vascular Architects, Inc. | 02/28/2001SE |
| K950813 | Mollring CutterDWX · Traditional | Cardio Vascular Concepts, Inc. | 07/25/1995SE |
| K933498 | External Vein StripperDWX · Traditional | Applied Medical Resources | 03/23/1994SE |
| K913803 | Intraluminal Artery StripperDWX · Traditional | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 04/24/1992SE |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. LineDWX · Traditional | Pilling Co. | 06/25/1991SE |
| K904944 | Transluminal Endarterectomy DeviceDWX · Traditional | Baxter Healthcare Corp | 12/17/1990SE |
| K895878 | Olympus Valvulotome W/Detachable TipDWX · Traditional | Olympus Corp. | 01/02/1990SE |
| K894496 | Olympus Valvulotome W/Fixed TipDWX · Traditional | Olympus Corp. | 10/12/1989SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K013680 | Carbodissecting EndoscopeGEI · Traditional | 03/04/2002SE |
Questions and answers
When was Carbodissecting Endoscope cleared by the FDA?
Carbodissecting Endoscope (K020925) received a 510(k) decision of Substantially Equivalent on April 29, 2003, 404 days after the submission was received.
What is the product code of K020925?
The FDA product code is DWX – Stripper, Artery, Intraluminal, a Class II (moderate risk) device regulated under 21 CFR 870.4875.