FDA product code SBG: In Situ Polymerizing Peripheral Nerve Cap
SBG is the FDA product code for in situ polymerizing peripheral nerve cap. It is a Class II device, regulated under 21 CFR 882.5260 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under SBG, 1 in the last five years. The average 510(k) review took 90 days (median 90); 90 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An in situ polymerizing peripheral nerve cap is a prescription use only device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve to function as a physical barrier to the surrounding in vivo environment to reduce the risk of formation of a symptomatic neuroma.
Classification
| Field | Value |
|---|---|
| Device name | In Situ Polymerizing Peripheral Nerve Cap |
| Device class | Class II |
| Regulation | 21 CFR 882.5260 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for SBG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every SBG clearance
Top SBG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tulavi Therapeutics, Inc. | 1 | 2025-09-29 |
Most recent SBG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252051 | Tulavi Therapeutics, Inc. | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | 2025-09-29 | 90 |
Recalls for SBG devices
openFDA lists no recalls for product code SBG.
Frequently asked questions
What is FDA product code SBG?
SBG is the FDA product code for in situ polymerizing peripheral nerve cap. It is a Class II device, regulated under 21 CFR 882.5260 and reviewed by the Neurology panel.
What device class is SBG?
Class II, regulation 21 CFR 882.5260. Typical premarket route: 510(k).
How long does a 510(k) take for product code SBG?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most SBG clearances?
Tulavi Therapeutics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SBG
- Run a recall and safety report across every SBG manufacturer
- Watch product code SBG 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.
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