← FDA Medical Device Classifications
Suture, Recombinant Technology
NWJ · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4494
Classification
- FDA Product Code
NWJ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4494
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Market data
- Cleared 510(k) submissions
- 9
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown