FDA product code SFD: In Situ Polymerizing Peripheral Nerve Repair Device
SFD is the FDA product code for in situ polymerizing peripheral nerve repair device. It is a Class II device, regulated under 21 CFR 882.5270 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under SFD, 1 in the last five years. The average 510(k) review took 75 days (median 75); 75 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 8 recalls for SFD devices, 8 initiated in the last five years.
Definition
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.
Classification
| Field | Value |
|---|---|
| Device name | In Situ Polymerizing Peripheral Nerve Repair Device |
| Device class | Class II |
| Regulation | 21 CFR 882.5270 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for SFD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 75 |
Compare with all 510(k) review times · Search every SFD clearance
Top SFD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tissium SA | 1 | 2025-09-08 |
Most recent SFD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251957 | Tissium SA | Coaptium Connect with Tissium Light | 2025-09-08 | 75 |
Recalls for SFD devices
8 product recalls in 1 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2026-06-15.
| Year | Recalls |
|---|---|
| 2026 | 8 |
Frequently asked questions
What is FDA product code SFD?
SFD is the FDA product code for in situ polymerizing peripheral nerve repair device. It is a Class II device, regulated under 21 CFR 882.5270 and reviewed by the Neurology panel.
What device class is SFD?
Class II, regulation 21 CFR 882.5270. Typical premarket route: 510(k).
How long does a 510(k) take for product code SFD?
Across 1 cleared submissions the average was 75 days from receipt to decision (median 75).
Which companies have the most SFD clearances?
Tissium SA (1).
Have SFD devices been recalled?
Yes: 8 product recalls across 1 recall events; the most recent began 2026-06-15.
Next steps
- Run an FDA pathway report with predicate devices for product code SFD
- Run a recall and safety report across every SFD manufacturer
- Watch product code SFD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times