Apparatus, Electrosurgical
FDA product code HAM · Class II (moderate risk) · 21 CFR 878.4400 · General, Plastic Surgery
31510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Olsen Electrosurgical, Inc. 5
- Beacon Laboratories, Inc. 4
- Medical Products Development, Inc. 2
- Edward Weck, Inc. 2
- Qmed, Inc. 1
- Itl Corporation Pty, Ltd. 1
- Paladin Medical, Inc. 1
- Bergen Mfg. 1
- Cook Ob/Gyn 1
- Emc Industries 1
- Nk-Optik GmbH 1
- New England Surgical Instrument Corp. 1
- C.R. Bard, Inc. 1
- Bio-Detek, Inc. 1
- Dlp, Inc. 1
- Squibb Diagnostics 1
- Trident Surgical Corp. 1
- Ndm Corp. 1
- Key Medical, Inc. 1
- Ritter Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153472 | Quiver Laparoscopic ExtendableHAM · Traditional | Itl Corporation Pty, Ltd. | 06/23/2016SE |
| K000079 | Nikopad Electrosurgical Grounding Pad, Model 4777MHAM · Special | Nikomed U.S.A., Inc. | 02/04/2000SE |
| K993306 | Nikopad Electrosurgical Grounding Pad (*Or Sold Under Commercial Names), Model 4760…HAM · Special | Paladin Medical, Inc. | 11/03/1999SE |
| K945861 | Bergen 710 EsuHAM · Traditional | Bergen Mfg. | 03/01/1995SE |
| K913300 | Laparostat(Tm)HAM · Traditional | Cook Ob/Gyn | 04/02/1992SE |
| K920100 | Gsu Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 02/03/1992SE |
| K911353 | Emc Model No. Statome 900HAM · Traditional | Emc Industries | 06/24/1991SE |
| K901248 | Abc Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 04/03/1990SE |
| K881334 | Light Coagulator LC 250HAM · Traditional | Nk-Optik GmbH | 11/16/1989SE |
| K895337 | Electrosurgical Coagulation Suction TubeHAM · Traditional | New England Surgical Instrument Corp. | 09/15/1989SE |
| K894762 | B100 Disposable HandpieceHAM · Traditional | Beacon Laboratories, Inc. | 09/15/1989SE |
| K894663 | Beamer OneHAM · Traditional | Beacon Laboratories, Inc. | 09/15/1989SE |
| K884175 | #820/821 Bipolar ForcepsHAM · Traditional | Olsen Electrosurgical, Inc. | 10/24/1988SE |
| K884174 | Modified Olsen 755/756 SwitchpensHAM · Traditional | Olsen Electrosurgical, Inc. | 10/24/1988SE |
| K884173 | #920 Disposable Tur CableHAM · Traditional | Olsen Electrosurgical, Inc. | 10/24/1988SE |
| K884172 | Modified Olsen #770 Disposable HolsterHAM · Traditional | Olsen Electrosurgical, Inc. | 10/24/1988SE |
| K884171 | #875 Disposable Biopolar CableHAM · Traditional | Olsen Electrosurgical, Inc. | 10/24/1988SE |
| K871435 | Bard EMS System 6000 E.S.U.HAM · Traditional | C.R. Bard, Inc. | 05/11/1987SE |
| K863091 | Bicord by QmedHAM · Traditional | Qmed, Inc. | 08/29/1986SE |
| K853291 | GP-100 Adult Electrosurgical Ground PAD/200 & 300HAM · Traditional | Bio-Detek, Inc. | 10/10/1985SE |
| K852184 | Electro-Cautery Knife Cleaner 6000 1HAM · Traditional | Dlp, Inc. | 06/04/1985SE |
| K833648 | Ophthalmic Cautery #6821-HOT-TEMP #'SHAM · Traditional | Edward Weck, Inc. | 11/29/1983SE |
| K823755 | Biceps Electrocautery SystemHAM · Traditional | Squibb Diagnostics | 01/26/1983SE |
| K820664 | Disposable ElectrodeHAM · Traditional | Trident Surgical Corp. | 03/19/1982SE |
| K810920 | NDM Diatemp Infant Electrosurg. Disp. P.HAM · Traditional | Ndm Corp. | 05/01/1981SE |
| K810909 | Micro CauteryHAM · Traditional | Key Medical, Inc. | 04/17/1981SE |
| K810015 | Multihi-Temp CauteryHAM · Traditional | Medical Products Development, Inc. | 02/12/1981SE |
| K810014 | Replacable Battery Hi-Temp CauteryHAM · Traditional | Medical Products Development, Inc. | 02/12/1981SE |
| K780293 | Electrosurgical UnitHAM · Traditional | Ritter Co. | 03/14/1978SE |
| K780118 | Electrode, Dispersive, Disp. NeopadHAM · Traditional | Neomed Corp. | 02/23/1978SE |
| K771186 | Micro Bi-Polar Forceps #39-200HAM · Traditional | Edward Weck, Inc. | 07/15/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0724-2013 Class II | ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R)…ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed… | ConMed Corporation | 12/27/2012Terminated |