Permacol
FDA 510(k) K021056 · Tissue Science Laboratories, Plc
510(k) numberK021056
Submission
- Device name
- Permacol
- Applicant
- Tissue Science Laboratories, Plc
Washington, DC, US - Received
- April 1, 2002
- Decision date
- October 31, 2002
- 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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More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K053562 | Zimmer Collagen Repair PatchFTM · Traditional | 06/23/2006SE |
| K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…PAI · Special | 03/09/2005SE |
| K043366 | Permacol Surgical ImplantFTL · Traditional | 12/17/2004SE |
| K013625 | PermacolFTM · Traditional | 01/17/2002SE |
| K992556 | PermacolFTL · Traditional | 02/17/2000SE |
Questions and answers
When was Permacol cleared by the FDA?
Permacol (K021056) received a 510(k) decision of Substantially Equivalent on October 31, 2002, 213 days after the submission was received.
What is the product code of K021056?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.