Apparatus, Electrosurgical
General, Plastic Surgery · 21 CFR 878.4400
Recent MDR events
59 adverse event reports on file
- MEDLINEJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07987
- MEDLINEJun 16, 2026MalfunctionMedline Industries,lp1417592-2026-02426
- MEDLINEMay 29, 2026MalfunctionMedline Industries, Lp1417592-2026-01903
- MEDLINEMay 29, 2026MalfunctionMedline Industries, Lp1417592-2026-01904
- MEDLINEMay 6, 2026MalfunctionMedline Industries, Lp1417592-2026-00969
- MEDLINEApr 15, 2026MalfunctionMedline Industries, Lp1417592-2026-00446
- ABCMar 18, 2026MalfunctionConmed3007305485-2026-00041
- CAUTERY, HIGH TEMP FINE TIPMar 13, 2026MalfunctionMedline Industries Lp1417592-2026-00222
- ABCMar 24, 2025InjuryConsolidated Medical Equipment Company3007305485-2025-00053
- ABCMar 24, 2025InjuryConsolidated Medical Equipment Company3007305485-2025-00054
Event type breakdown
Recalls
3 recall events for this product code
- ConMed CorporationTerminatedJan 24, 2013
ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R) Handpiece), REF/Catalog No. 130343, Sterile, Rx ONLY -- CONMED CORPORATION Electr
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
Z-0724-2013 · View FDA record ↗ - Valleylab, IncTerminatedAug 12, 2003
Radionics Disposable Grounding Plate
Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
Z-1121-03 · View FDA record ↗ - Valleylab, IncTerminatedAug 12, 2003
Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.
Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
Z-1122-03 · View FDA record ↗
Registered firms
46 firms currently registered for this product code
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Beaver-visitec International, Inc.
Ciudad Juarez Chihuahua, MX
Sterigenics U.s., Llc
Queensbury, NY, US
Isomedix Operations Inc
GROVEPORT, OH, US
Conmed Corporation
Utica, NY, US
Isomedix Operations Inc.
CHESTER, NY, US
Deroyal Industries, Inc.
POWELL, TN, US
Synergy Sterilisation (m) Sdn Bhd
Kuala Ketil Kedah, MY
Medtronic Grand Rapids
Grand Rapids, MI, US
Parker Laboratories, Inc.
FAIRFIELD, NJ, US
Nikomed U.s.a., Inc.
Hatboro, PA, US
Kirwan Surgical Products, Llc.
MARSHFIELD, MA, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Sterigenics Us, Llc
Lewis Center, OH, US
Conmed Corporation
Greenwood Village, CO, US
Isomedix Operations Inc.
SPARTANBURG, SC, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Isomedix Operations Inc.
Northborough, MA, US
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
Weco Manufacturing Group-henrietta
Rochester, NY, US
510(k) clearances
31 clearances for this product code
- Itl Corporation Pty, Ltd.Jun 23, 2016
K153472 · Quiver Laparoscopic Extendable
- Nikomed U.S.A., Inc.Feb 4, 2000
K000079 · NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
- Paladin Medical, Inc.Nov 3, 1999
K993306 · NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
- Bergen Mfg.Mar 1, 1995
K945861 · BERGEN 710 ESU
- Cook Ob/GynApr 2, 1992
K913300 · LAPAROSTAT(TM)
- Beacon Laboratories, Inc.Feb 3, 1992
K920100 · GSU HANDPIECE ADAPTER
- Emc IndustriesJun 24, 1991
K911353 · EMC MODEL NO. STATOME 900
- Beacon Laboratories, Inc.Apr 3, 1990
K901248 · ABC HANDPIECE ADAPTER