ClearanceBrief
Company ยท FR

TISSIUM SA

FDA 510(k) clearances and medical device recalls filed under this name, 2025 to 2025. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
8recalls (8 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
SFDIn Situ Polymerizing Peripheral Nerve Repair Device10

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 8, 2025K251957Coaptium Connect with Tissium Light
Tissium SA, FR
SFD
Jun 17, 2025DEN240066COAPTIUM Connect with TISSIUM LIGHT
Tissium SA, FR
SFD

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Open, Classified
SFDNone listed
Aug 6, 2026TISSIUM SA
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/
Open, Classified
SFDNone listed
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