MFJClass II
Device, Endoscopic Suturing
Gastroenterology, Urology · 21 CFR 876.1500
MDR events843All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
843 adverse event reports on file
- DEK BL MF 0 TC-43 2N 48Mar 10, 2023MalfunctionTeleflex Medical3004365956-2023-00016
- Unnamed deviceSep 26, 2018MalfunctionCovidien Lp Llc North Haven1219930-2018-05242
- ENDO STITCH AUTO SUTURING DEVICEJun 26, 2017InjuryCovidienMW5070672
- DEK BL MF 0 TC-43/HR 26 2N 36"Apr 3, 2017MalfunctionTeleflex Medical3004365956-2017-00114
- DEK BL MF 0 TC-43/HR 26 2N 36"Mar 14, 2017MalfunctionTeleflex Medical3004365956-2017-00100
- ENDOSTITCHJan 4, 2017MalfunctionCovidien Lp6221217
- ENDOSTITCHNov 28, 2016MalfunctionCovidien (medtronic)6128550
- CAPIO SUTURE DEVICEMay 13, 2016InjuryBoston ScientificMW5062327
- DEK BL MF 0 TC-43/HR 26 2N 36"Apr 25, 2016MalfunctionTeleflex Medical3004365956-2016-00201
- ENDO STITCHMar 9, 2016InjuryCovidien5488639
Event type breakdown
Malfunction638
Injury167
Other22
Unspecified15
Death1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code