Cuffpatch
FDA 510(k) K042809 · Organogenesis, Inc.
510(k) numberK042809
Submission
- Device name
- Cuffpatch
- Applicant
- Organogenesis, Inc.
Canton, MA, US - Received
- October 12, 2004
- Decision date
- November 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Cuffpatch cleared by the FDA?
Cuffpatch (K042809) received a 510(k) decision of Substantially Equivalent on November 2, 2004, 21 days after the submission was received.
What is the product code of K042809?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.