FARClass II
Unit, Electrosurgical
Gastroenterology, Urology · 21 CFR 876.4300
MDR events27All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
27 adverse event reports on file
- SYSTEM 5000 ESUNov 20, 2015InjuryConmed Electrosurgery1720159-2015-00004
- VALLEYLAB FORCEDec 13, 2013MalfunctionCovidien3890035
- BIRTCHERMay 13, 2005MalfunctionConmed Electrosurgery1720159-2005-00011
- VALLEYLAB ESUFeb 13, 1995InjuryValleylab19700
- BIRTCHERJan 10, 1995InjuryBirtcher Medical Systems, Inc.24987
- ELECTROSURGICAL CABINETSep 23, 1994MalfunctionValley Labs, Inc.8965
- ELECTRICOSURGICAL UNITJul 29, 1994MalfunctionValleylab Inc. A Pfizer Co.9064
- 4400 POWER PLUSJul 29, 1994MalfunctionBirtcher Medical System9276
- ELECTROSURGICAL UNITSep 2, 1993InjuryValleylab20887
- ELECTROSURGICAL UNIT/FOOT PEDALAug 16, 1993InjuryValleylab6269
Event type breakdown
Injury21
Malfunction5
Unspecified1
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
0 clearances for this product code
No 510(k) clearances on file for this product code.