SBGClass II
In Situ Polymerizing Peripheral Nerve Cap
21 CFR 882.5260 / Neurology
SBG is the FDA product code for In Situ Polymerizing Peripheral Nerve Cap, a class II device type, regulated under 21 CFR 882.5260. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SBG
- Device name
- In Situ Polymerizing Peripheral Nerve Cap
- FDA 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.
- Regulation
- 21 CFR 882.5260
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code SBG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code SBG| Applicant | Clearances |
|---|---|
| Tulavi Therapeutics | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.