510(k) K191234
- Device
- APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC Probes, Hybrid APC, APCapplicators, APC Pressure Reducer With Sensor, VIO Cart, Fastening Sets
- Applicant
- Erbe Elektromedizin GmbH
- 510(k) number
- K191234
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-12-20
- Date received
- 2019-05-08
- 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
- Henry Kutz
- Address
- Waldhoernlestrasse 17 Tuebingen DE 72072 72072
FDA Registration Numbers#
- 1123137
- 3016746323
- 2954783
- 3006451981
- 2245304
- 2150060
- 3003678543
- 3004215117
- 3004105270
- 8010047
- 3010511300
- 1060680
- 3040993693
- 3013500228
- 3032391
- 3008215723
- 3009903460
- 3005562917
- 3005064943
- 3010041511
- 1923569
- 3008791915
- 3010687973
- 3005350457
- 3012460907
- 3010432890
- 3008729892
- 3010131466
- 3006990600
- 9616696
- 9613793
- 3013563737
- 3020623326
- 3010131137
- 3009420598
- 3015173212
- 3005083075
- 3015453963
- 1724474
- 3004519921
- 3033589330
- 1313525
- 3027339877
- 2183319
- 3013734919
- 3008720584
- 3014939461
- 3004636440
- 3012497308
- 3031916226
- 3016087306
- 9614279
- 3027988352
- 9680001
- 3002858762
- 3015241782
- 3008816935
- 3013111980
- 2030598
- 1418975
- 3002807090
- 2183785
- 3007710878
- 9680515
- 3015460875
- 3017202975
- 9680952
- 9611612
- 3016248634
- 3001675293
- 3009166798
- 3043532708
- 3038988287
- 2529846
- 3007791595
- 3003755939
- 1820334
- 1219930
- 3008849319
Source Documents#
Other 510(k) Records For Product Code GEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 |
| K253917 | ARION ARC System | Plasma Surgical, Inc. | 2026-04-10 |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | 2026-04-07 |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026-04-06 |
| K253405 | Prana System | Prana Surgical | 2026-04-01 |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | 2026-03-30 |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | 2026-03-27 |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | 2026-03-25 |
| K253750 | BTL-785NEH | BTL Industries, Inc. | 2026-03-17 |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | 2026-03-02 |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | 2026-02-24 |
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