510(k) K082178
- Device
- TEPHAFLEX ABSORBABLE SUTURE
- Applicant
- TEPHA, INC.
- 510(k) number
- K082178
- Product code
- NWJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-30
- Date received
- 2008-08-01
- Regulation
- 878.4494
- Classification name
- Suture, Recombinant Technology
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY P LEGRAW
- Address
- 99 Hayden Ave. Suite 360 Lexington MA US 02421 02421
FDA Registration Numbers#
- 3003639970
- 2183744
- 1649390
Source Documents#
Other 510(k) Records For Product Code NWJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211307 | GalaSTITCH Absorbable Monofilament Suture | Tepha, Inc. | 2021-05-27 |
| K132348 | TEPHAFLEX BRAIDED SUTURE | Tepha, Inc. | 2013-09-05 |
| K130422 | PHANTOM FIBER BIOFIBER SUTURE | Tornier, Inc. | 2013-04-04 |
| K122487 | BIOFIBER SYTURE | Tornier, Inc. | 2012-09-17 |
| K100876 | AESCULAP MONOMAX ABSORBABLE SUTURE | Aesculap, Inc. | 2010-07-14 |
| K081099 | TEPHAFLEX ABSORBABLE SUTURE | Tepha, Inc. | 2008-07-15 |
| K072470 | BIOELAST 5-0 SUTURE, MODEL 500100 | Entrigue Surgical, Inc. | 2007-11-16 |
| DEN060003 | TEPHAFLEX ABSORBABLE SUTURE | Tepha, Inc. | 2007-02-08 |
Legacy Summary#
summary
FDA Review#
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