Surgisis
FDA 510(k) K980431 · Cook Biotech, Inc.
510(k) numberK980431
Submission
- Device name
- Surgisis
- Applicant
- Cook Biotech, Inc.
West Lafayette, IN, US - Received
- February 4, 1998
- Decision date
- May 28, 1998
- 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 Surgisis cleared by the FDA?
Surgisis (K980431) received a 510(k) decision of Substantially Equivalent on May 28, 1998, 113 days after the submission was received.
What is the product code of K980431?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.