510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251957Substantially Equivalent

Coaptium Connect with Tissium Light

Tissium SA, Paris, FR / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251957 is the FDA 510(k) clearance record for Coaptium Connect with Tissium Light, a class II device, cleared for Tissium SA on under FDA product code SFD (In Situ Polymerizing Peripheral Nerve Repair Device). FDA's definition for product code SFD reads: "An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries". FDA records list 2 510(k) clearances for Tissium SA, from to . As of , FDA records show no recalls naming K251957.

Clearance record

Decision date
Received
(75 days to decision)
Product code
SFD In Situ Polymerizing Peripheral Nerve Repair Device
Regulation
21 CFR 882.5270
Device class
Class II
Review panel
Neurology
Applicant
Tissium SA 74 Rue Du Faubourg Saint Antoine, Paris, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SFD

Trailing 12 months

FDA records hold no clearances under product code SFD in the trailing twelve months.

FDA records show no clearances under product code SFD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260