510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SFDClass II

In Situ Polymerizing Peripheral Nerve Repair Device

21 CFR 882.5270 / Neurology
FDA source (opens on fda.gov)

SFD is the FDA product code for In Situ Polymerizing Peripheral Nerve Repair Device, a class II device type, regulated under 21 CFR 882.5270. FDA's definition for this code reads: "An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
SFD
Device name
In Situ Polymerizing Peripheral Nerve Repair Device
FDA definition
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.
Regulation
21 CFR 882.5270
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
8

Clearances, product code SFD

By decision year
2 clearances under product code SFD with a decision year between 2025 and 2025, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SFD by decision year
YearClearances
20252

Applicants with the most clearances

Product code SFD
Applicants holding the most 510(k) clearances under product code SFD
ApplicantClearances
Tissium SA2

Companies listing this code with FDA

Companies whose registered establishments list this code