PDS Polydioxanone Mesh
FDA 510(k) K844228 · ETHICON, Inc.
510(k) numberK844228
Submission
- Device name
- PDS Polydioxanone Mesh
- Applicant
- ETHICON, Inc.
Somerville, NJ, US - Received
- November 1, 1984
- Decision date
- January 24, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was PDS Polydioxanone Mesh cleared by the FDA?
PDS Polydioxanone Mesh (K844228) received a 510(k) decision of Substantially Equivalent on January 24, 1985, 84 days after the submission was received.
What is the product code of K844228?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.