← Product Code [NWJ](/submissions/SU/subpart-e%E2%80%94surgical-devices/NWJ) · DEN060003

# TEPHAFLEX ABSORBABLE SUTURE (DEN060003)

_Tepha, Inc. · NWJ · Feb 8, 2007 · General, Plastic Surgery · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NWJ/DEN060003

## Device Facts

- **Applicant:** Tepha, Inc.
- **Product Code:** [NWJ](/submissions/SU/subpart-e%E2%80%94surgical-devices/NWJ.md)
- **Decision Date:** Feb 8, 2007
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 878.4494
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NWJ/DEN060003](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NWJ/DEN060003)

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