Product code HAM
- Device name
- Apparatus, Electrosurgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4400
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153472 | Quiver Laparoscopic Extendable | Itl Corporation Pty, Ltd. | 2016-06-23 |
| K000079 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | Nikomed U.S.A., Inc. | 2000-02-04 |
| K993306 | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) | Paladin Medical, Inc. | 1999-11-03 |
| K945861 | BERGEN 710 ESU | Bergen Mfg. | 1995-03-01 |
| K913300 | LAPAROSTAT(TM) | Cook Ob/Gyn | 1992-04-02 |
| K920100 | GSU HANDPIECE ADAPTER | Beacon Laboratories, Inc. | 1992-02-03 |
| K911353 | EMC MODEL NO. STATOME 900 | Emc Industries | 1991-06-24 |
| K901248 | ABC HANDPIECE ADAPTER | Beacon Laboratories, Inc. | 1990-04-03 |
| K881334 | LIGHT COAGULATOR LC 250 | Nk-Optik GmbH | 1989-11-16 |
| K895337 | ELECTROSURGICAL COAGULATION SUCTION TUBE | New England Surgical Instrument Corp. | 1989-09-15 |
| K894663 | BEAMER ONE | Beacon Laboratories, Inc. | 1989-09-15 |
| K894762 | B100 DISPOSABLE HANDPIECE | Beacon Laboratories, Inc. | 1989-09-15 |
| K884171 | #875 DISPOSABLE BIOPOLAR CABLE | Olsen Electrosurgical, Inc. | 1988-10-24 |
| K884172 | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | Olsen Electrosurgical, Inc. | 1988-10-24 |
| K884173 | #920 DISPOSABLE TUR CABLE | Olsen Electrosurgical, Inc. | 1988-10-24 |
| K884174 | MODIFIED OLSEN 755/756 SWITCHPENS | Olsen Electrosurgical, Inc. | 1988-10-24 |
| K884175 | #820/821 BIPOLAR FORCEPS | Olsen Electrosurgical, Inc. | 1988-10-24 |
| K871435 | BARD EMS SYSTEM 6000 E.S.U. | C.R. Bard, Inc. | 1987-05-11 |
| K863091 | BICORD BY QMED | Qmed, Inc. | 1986-08-29 |
| K853291 | GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 | Bio-Detek, Inc. | 1985-10-10 |
| K852184 | ELECTRO-CAUTERY KNIFE CLEANER 6000 1 | Dlp, Inc. | 1985-06-04 |
| K833648 | OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S | Edward Weck, Inc. | 1983-11-29 |
| K823755 | BICEPS ELECTROCAUTERY SYSTEM | Squibb Diagnostics | 1983-01-26 |
| K820664 | DISPOSABLE ELECTRODE | Trident Surgical Corp. | 1982-03-19 |
| K810920 | NDM DIATEMP INFANT ELECTROSURG. DISP. P. | Ndm Corp. | 1981-05-01 |
| K810909 | MICRO CAUTERY | Key Medical, Inc. | 1981-04-17 |
| K810015 | MULTIHI-TEMP CAUTERY | Medical Products Development, Inc. | 1981-02-12 |
| K810014 | REPLACABLE BATTERY HI-TEMP CAUTERY | Medical Products Development, Inc. | 1981-02-12 |
| K780293 | ELECTROSURGICAL UNIT | Ritter Co. | 1978-03-14 |
| K780118 | ELECTRODE, DISPERSIVE, DISP. NEOPAD | Neomed Corp. | 1978-02-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10841019117573 | Kirwan | KIRWAN SURGICAL PRODUCTS LLC | 2025-04-07 |
| 10841019117566 | Kirwan | KIRWAN SURGICAL PRODUCTS LLC | 2025-04-07 |
| 10841019117559 | Kirwan | KIRWAN SURGICAL PRODUCTS LLC | 2025-04-07 |
| 00841019117552 | Kirwan | KIRWAN SURGICAL PRODUCTS LLC | 2025-04-07 |
| 00841019117569 | Kirwan | KIRWAN SURGICAL PRODUCTS LLC | 2025-04-07 |
| 00841019117576 | Kirwan | KIRWAN SURGICAL PRODUCTS LLC | 2025-04-07 |
| 00653405002102 | CONMED | Conmed Corporation | 2023-11-30 |
| 20653405036019 | ABC | Conmed Corporation | 2023-10-11 |
| 14026704662118 | PILLING | TELEFLEX INCORPORATED | 2019-06-03 |
| 19555240400854 | ITL Essential Laparoscopic Quiver Extendable | ITL ASIA PACIFIC SDN. BHD. | 2019-05-25 |
| 19555240401141 | ITL Essential Standard Quiver | ITL ASIA PACIFIC SDN. BHD. | 2019-05-25 |
| 14026704662125 | WECK | TELEFLEX INCORPORATED | 2019-05-08 |
| 20653405002601 | ABC | Conmed Corporation | 2016-09-24 |
| 10653405002475 | ABC | Conmed Corporation | 2016-09-24 |
| 20653405002472 | ABC | Conmed Corporation | 2016-09-24 |
| 30653405002103 | CONMED | Conmed Corporation | 2016-09-24 |
| 30653405036016 | ABC | Conmed Corporation | 2016-09-24 |
| 10653405002604 | ABC | Conmed Corporation | 2016-09-24 |
| 04026704599851 | PILLING | TELEFLEX INCORPORATED | 2016-09-16 |
| 04026704599882 | WECK | TELEFLEX INCORPORATED | 2016-09-16 |
| 00841785109126 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-13 |
| 00841785109140 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-13 |
| 00841785109119 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-07 |
| 00841785109133 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-07 |
| 00841785109157 | Symmetry Olsen | ASPEN SURGICAL PRODUCTS, INC. | 2016-09-06 |
| 00841019110072 | Sense Medical | SENSE MEDICAL LLC | 2016-07-16 |
| 00841019110232 | MytaMed | Mytamed, Inc. | 2016-07-10 |
| 00841019108147 | Kirwan | KIRWAN SURGICAL PRODUCTS LLC | 2016-05-04 |
| 00841019107409 | Kirwan | KIRWAN SURGICAL PRODUCTS LLC | 2016-05-04 |
| 00841019107393 | Kirwan | KIRWAN SURGICAL PRODUCTS LLC | 2016-05-04 |