510(k) K912070
- Device
- SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT
- Applicant
- SIEMENS MEDICAL ELECTRONICS
- 510(k) number
- K912070
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-04-23
- Date received
- 1991-05-10
- 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
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT R MURFITT
- Address
- 16 Electronics Ave. Danvers MA US 01923 01923
FDA Registration Numbers#
- 3006985163
- 3006266622
- 2133786
- 3004044817
- 3025606176
- 2938071
- 3013686892
- 3026612481
- 1221826
- 3020899789
- 3008824097
- 3009380063
- 3002579136
- 3006985208
- 3014279513
- 1320894
- 2424366
- 8010890
- 3009719225
- 3016076698
- 3010432890
- 2182269
- 3004598644
- 3006950086
- 3007712511
- 3005064943
- 3011137372
- 3015967359
- 3008747667
- 1721686
- 9616666
- 9611612
- 3004748528
- 3009217531
- 1718850
- 3013700547
- 3033715699
- 2183870
- 2650143
- 1717344
- 3043585137
- 3007645866
- 3045753434
- 3004777218
- 1721504
- 9611112
- 9616675
- 3043226252
- 2954783
- 3004491689
- 3012460907
- 3010684280
- 3006897899
- 9611102
- 3027339887
- 3008929787
- 3006546082
- 3014328942
- 3008571754
- 3006747129
- 1037007
- 3015895145
- 1526012
- 1820334
- 9611827
- 1220246
- 3007791595
- 3004060780
- 2320762
- 3009882464
- 1720929
- 3007200016
- 3031944951
- 3011423170
- 3017406274
- 3047841690
- 3010173425
- 3004361445
- 3029754081
Source Documents#
Other 510(k) Records For Product Code GEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262720 | SP Electrocautery Device (SP18 Max);SP Electrocautery Device (SP20 Max) | Single Pass, Inc. | 2026-10-26 |
| K262386 | SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) | Stryker Instruments | 2026-10-20 |
| 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 |
Legacy Summary#
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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