Peripatch Endo-Sleeve
FDA 510(k) K063556 · Pm Devices, Inc.
510(k) numberK063556
Submission
- Device name
- Peripatch Endo-Sleeve
- Applicant
- Pm Devices, Inc.
Richmond, CA - Received
- November 27, 2006
- Decision date
- March 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K040835 | Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16FTM · Traditional | 06/15/2004SE |
| K033985 | Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10FTM · Traditional | 06/04/2004SE |
| K031948 | Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16DXZ · Traditional | 09/16/2003SE |
Questions and answers
When was Peripatch Endo-Sleeve cleared by the FDA?
Peripatch Endo-Sleeve (K063556) received a 510(k) decision of Substantially Equivalent on March 20, 2007, 113 days after the submission was received.
What is the product code of K063556?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.