510(k) K991855
- Device
- CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX
- Applicant
- CONMED CORP.
- 510(k) number
- K991855
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-06-15
- Date received
- 1999-06-01
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- IRA D DUESLER JR
- Address
- 310 Broad St. Utica NY US 13501 13501
FDA Registration Numbers#
- 3016851379
- 1650907
- 3027669735
- 1219619
- 2182536
- 8043548
- 3040993693
- 3009941480
- 1820334
- 3035482729
- 1828132
- 3004464325
- 1000121056
- 3007007790
- 3010805941
- 1718850
- 3006891611
- 3013557562
- 3016727307
- 3012204368
- 3030645016
- 3010739934
- 3015471899
- 9611516
- 9612086
- 3009241989
- 3029916132
- 3013944123
- 3008870565
- 3004638532
- 3021008900
- 8010047
- 2182291
- 1221934
- 3004491689
- 3005075853
- 3012470322
- 3021226419
- 3012497308
- 3011024991
- 3021519357
- 2150060
- 3020899789
- 3007185043
- 3017185164
- 3011270181
- 3010402752
- 3009762450
- 2011171
- 1423662
- 3010377594
- 2133928
- 3010806467
- 3044156918
- 3042940623
- 3006059917
- 3003767927
- 3012453745
- 1526711
- 1319660
- 3012507533
- 2938071
- 1928237
- 1223422
- 2031093
- 3000236920
- 3008770252
- 3010511300
- 3006897899
- 1056350
- 3015183635
- 3006891627
- 3005099803
- 3002807090
- 8044057
- 8010273
- 8030967
- 3013298431
- 3016607092
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026-06-02 |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | 2026-05-29 |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | 2026-05-26 |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | 2026-05-20 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases