Renasys F/-Ab Abdominal Wound Dressing Kit
FDA 510(k) K100787 · Smith & Nephew, Inc.
510(k) numberK100787
Submission
- Device name
- Renasys F/-Ab Abdominal Wound Dressing Kit
- Applicant
- Smith & Nephew, Inc.
St Petersburg, FL, US - Received
- March 19, 2010
- Decision date
- September 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTL – Mesh, Surgical, Polymeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K243315 | ProGrip Self-Gripping Polypropylene MeshFTL · Traditional | Sofradim Production | 01/17/2025SE |
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| K233402 | Bard 3DMax MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 11/01/2023SE |
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Questions and answers
When was Renasys F/-Ab Abdominal Wound Dressing Kit cleared by the FDA?
Renasys F/-Ab Abdominal Wound Dressing Kit (K100787) received a 510(k) decision of Substantially Equivalent on September 17, 2010, 182 days after the submission was received.
What is the product code of K100787?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.