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

Roncq Nord, FR

TISSIUM SA appears in FDA device records in Roncq Nord, FR. FDA records list 2 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
8
Registered establishments
3

510(k) clearance history

FDA records hold 2 510(k) clearances for Tissium SA in 2025.

Clearances by year, as a table
510(k) clearance decisions for Tissium SA, by decision year
YearClearances
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251957Coaptium Connect with Tissium LightSFDSubstantially Equivalent
DEN240066COAPTIUM Connect with TISSIUM LIGHTSFDUnknown

Registered establishments

FDA registered establishments for Tissium SA, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30329486333032948633TISSIUM Inc245 Main St, Cambridge, MA 02142 US2026No device listings on this registration
30155462003015546200TISSIUM SATISSIUM F1 Manufacturing Site, Roncq Nord 59223 FR2026
30214533073021453307TISSIUM SA18 Avenue Leon Gaumont, Paris 20e Arrondissement 75020 FR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2908-2026Brand 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: NoCurrently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.Class IIOpen, Classified
Z-2907-2026Brand 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: NoCurrently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.Class IIOpen, Classified
Z-2906-2026Brand 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: NoCurrently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.Class IIOpen, Classified
Z-2905-2026Brand 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: NoCurrently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.Class IIOpen, Classified
Z-2904-2026Brand 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: NoCurrently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.Class IIOpen, Classified
Z-2903-2026Brand 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: NoCurrently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.Class IIOpen, Classified
Z-2902-2026Brand 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: NoCurrently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.Class IIOpen, Classified
Z-2901-2026Brand 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/ACurrently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain