SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
FDA 510(k) K220981 · Fehling Surgical Instruments, Inc.
510(k) numberK220981
Submission
- Device name
- SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
- Applicant
- Fehling Surgical Instruments, Inc.
Kennesaw, GA, US - Received
- April 4, 2022
- Decision date
- April 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWP – Dilator, Vessel, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4475
- Specialty
- Cardiovascular
Other 510(k)s with product code DWP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183438 | Geomed Vascular DilatorsDWP · Traditional | Geomed Medizin-Technik GmbH & Co. | 09/03/2019SE |
| K163524 | Vessel DilatorDWP · Traditional | Fetzer Medical GmbH & Co. KG | 06/29/2017SE |
| K130896 | Vascular Probe, Vascular Probe EsDWP · Traditional | Synovis Life Technologies, Inc. | 04/24/2013SE |
| K100518 | Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054DWP · Traditional | Instrumed International, Inc. | 08/31/2010SE |
| K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel DilatorsDWP · Traditional | Geister Medizin Technik GmbH | 07/12/2003SE |
| K960312 | Rdi Cardiac Insulation PadDWP · Traditional | R D Intl. | 04/19/1996SE |
| K912548 | Lemaitre-Bookwalter Vessel DevicesDWP · Traditional | Vascutech, Inc. | 09/18/1991SE |
| K911475 | Laparoscopic Vessel ArticulatorDWP · Traditional | United States Endoscopy Group, Inc. | 07/02/1991SE |
| K910682 | Robicsek Probe/RetractorDWP · Traditional | Bio-Vascular, Inc. | 05/08/1991SE |
| K905159 | Flo-Rester(R) Vessel SizerDWP · Traditional | Bio-Vascular, Inc. | 02/07/1991SE |
Questions and answers
When was SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe cleared by the FDA?
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (K220981) received a 510(k) decision of Substantially Equivalent on April 20, 2023, 381 days after the submission was received.
What is the product code of K220981?
The FDA product code is DWP – Dilator, Vessel, Surgical, a Class II (moderate risk) device regulated under 21 CFR 870.4475.