Prowick
FDA 510(k) K083007 · Arthrex, Inc.
510(k) numberK083007
Submission
- Device name
- Prowick
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- October 8, 2008
- Decision date
- April 8, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
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Questions and answers
When was Prowick cleared by the FDA?
Prowick (K083007) received a 510(k) decision of Substantially Equivalent on April 8, 2009, 182 days after the submission was received.
What is the product code of K083007?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.