510(k) K885172
- Device
- Additional Electrosurgical Ground Pads
- Applicant
- CONMED CORP.
- 510(k) number
- K885172
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-06
- Date received
- 1988-12-13
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM W ABRAHAM
- Address
- 310 Broad St. Utica NY US 13501 13501
FDA Registration Numbers#
- 3022327202
- 3045816907
- 3017196117
- 3007675948
- 3030926959
- 3005809810
- 3031841433
- 3011277660
- 3009555600
- 3011270181
- 3005467144
- 2183613
- 3012616488
- 3010432890
- 1056128
- 3005012805
- 2011171
- 3012329552
- 3011070163
- 3015612252
- 3035642068
- 3019569846
- 3004636440
- 3008747667
- 1219602
- 2936485
- 3010361165
- 9610877
- 3015806723
- 3043532708
- 1219619
- 3009762450
- 3038715747
- 3004904811
- 1018233
- 3011050570
- 3030176940
- 2027460
- 3013011598
- 2085947
- 1721983
- 3006897899
- 3006985208
- 3041276591
- 3036803067
- 3031944951
- 1718873
- 3038988287
- 8010871
- 8030607
- 3016099036
- 3015539532
- 3010816547
- 9680837
- 1643264
- 1417592
- 3005770916
- 3010493171
- 3008132398
- 2182291
- 3014122529
- 3004111573
- 3030645016
- 8010877
- 3015895045
- 9613793
- 3009746061
- 1030451
- 3040335671
- 3013438730
- 2529846
- 3001675293
- 3009973505
- 2126666
- 3012428212
- 3015231789
- 3010356635
- 2435119
- 3015515531
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | 2026-09-17 |
| K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | Stryker Instruments | 2026-09-17 |
| K261070 | LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | 2026-09-15 |
| K254185 | Potenza Prime | Jeisys Medical Incorporated | 2026-09-11 |
| K262364 | Ellian Enigma RF Device | Ellian Corp | 2026-09-02 |
| K253859 | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | 2026-08-27 |
| K252535 | Inno-Switch™ Laparoscopic Instruments | Taiwan Surgical Corporation | 2026-08-25 |
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026-07-22 |
| K253504 | Volnewmer™ | Classys, Inc. | 2026-07-13 |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | 2026-07-01 |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | 2026-06-18 |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 |