GEIFDA Class 2 · 21 CFR 878.4400
Electrosurgical, Cutting & Coagulation & Accessories
Device family · General, Plastic Surgery
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
2,296
Manufacturers
219
Flagged signals
55
Adverse-event reports
93,155
Code matrix
| FDA product code | GEI |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 3 | 498.8 | 1,036 |
| Other | 2010 | 9 | 427.6 | 3,420 |
| Other | 2010 | 23 | 300.1 | 6,566 |
| Other | 2024 | 30 | 256.0 | 7,371 |
| Other | 2010 | 56 | 239.1 | 13,038 |
| Other | 2011 | 29 | 227.1 | 6,307 |
| Other | 2010 | 4 | 177.3 | 537 |
| Other | 2011 | 36 | 153.6 | 5,309 |
| Other | 2010 | 20 | 133.1 | 2,493 |
| Other | 2011 | 17 | 113.1 | 1,780 |
| Other | 2010 | 6 | 107.8 | 533 |
| Other | 2014 | 11 | 86.1 | 843 |
| Other | 2012 | 11 | 86.1 | 843 |
| Other | 2010 | 13 | 60.5 | 703 |
| Other | 2013 | 39 | 59.4 | 2,182 |
| Other | 2013 | 5 | 56.4 | 220 |
| Other | 2012 | 12 | 55.8 | 593 |
| Other | 2010 | 13 | 55.4 | 642 |
| Other | 2011 | 17 | 53.3 | 822 |
| Other | 2010 | 7 | 46.6 | 268 |
| Other | 2012 | 18 | 42.3 | 686 |
| Other | 2011 | 15 | 40.2 | 536 |
| Other | 2013 | 5 | 39.1 | 150 |
| Other | 2010 | 11 | 34.5 | 326 |
| Other | 2009 | 8 | 34.1 | 225 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 93,155 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Arthrocare Corp. | 64 | 2010 | — |
| Valleylab, Inc. | 60 | 2003 | — |
| Conmedcorp | 43 | 2010 | — |
| MEGADYNE MEDICAL PRODUCTS, INC. | 32 | 2024 | — |
| Aaron Medical Industries | 27 | 2006 | — |
| Conmed Corporation | 25 | 2023 | — |
| Aspen Laboratories, Inc. | 24 | 1998 | — |
| ArthroCare Corporation | 22 | 2026 | — |
| Covidien | 21 | 2019 | — |
| Gyrus ACMI, Inc. | 20 | 2026 | — |
| Covidien, LLC | 18 | 2024 | — |
| AESCULAP, INC. | 18 | 2020 | — |
| Ethicon Endo-Surgery, LLC | 14 | 2023 | — |
| OLYMPUS Winter & Ibe GmbH | 13 | 2025 | — |
| Bovie Medical Corporation | 13 | 2019 | — |
| Boston Scientific Corp | 13 | 2014 | — |
| Unimed Surgical Products, Inc. | 12 | 2013 | — |
| BTL Industries, Inc. | 12 | 2026 | — |
| KARL STORZ Endoscopy-America, Inc. | 12 | 2017 | — |
| Erbe Elektromedizin GmbH | 11 | 2025 | — |
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 11 | 2003 | — |
| Concept, Inc. | 10 | 1985 | — |
| ETHICON ENDO-SURGERY, INC. | 10 | 2010 | — |
| Smith & Nephew, Inc. | 10 | 2009 | — |
| Sutter Medizintechnik GmbH | 9 | 2026 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
ARION ARC System · Plasma Surgical, Inc.510(k) · 2026-04-10
Ascblue (8010) · Ascblue Corporation510(k) · 2026-04-10
Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) · Zhejiang shuyou Surgical Instrument Co., Ltd.510(k) · 2026-04-07
SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) · Hironic Co., Ltd.510(k) · 2026-04-06
Prana System · Prana Surgical510(k) · 2026-04-01
FLOW FLEXTEND Wand (72290039) · ArthroCare Corporation510(k) · 2026-03-30
AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) · Aventix Medical, Inc.510(k) · 2026-03-27
LYNX COBLATION Laryngeal Wand (72290254) · ArthroCare Corporation510(k) · 2026-03-25
BTL-785NEH · BTL Industries, Inc.510(k) · 2026-03-17
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) · Gyrus Acmi, Inc.510(k) · 2026-03-02
SP Electrocautery Device (SP20) · Single Pass, Inc.510(k) · 2026-02-24
CURIS II RF Generator (REF 360100-05) · Sutter Medizintechnik GmbH510(k) · 2026-02-11
Dermatrix Duo · Shenzhen Gsd Technology Co., Ltd.510(k) · 2026-02-06
ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) · Shenzhen Peninsula Medical Group510(k) · 2026-01-30
Reusable 3 Button Fingerswitch Wand · Soniquence, LLC510(k) · 2026-01-27
InbellaIgnite RF System · Inbella Medical, Inc.510(k) · 2026-01-27
Ignite RF System · InMode , Ltd.510(k) · 2026-01-15
ENTire IRE System · Entire Medical , Ltd.510(k) · 2026-01-14
Boston iFace (Boston iFace) · Boston Aesthetics, Inc.510(k) · 2026-01-12
MOVIVA® Hybrid Ablation Probe · Erbe Elektromedizin GmbH510(k) · 2025-12-18
F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) · F Care Systems USA, LLC510(k) · 2025-11-24
TS-RF Generator (STS10) · Starmed Co., Ltd.510(k) · 2025-11-17
Venus Nova (FP-2001) · Venus Concept, Inc.510(k) · 2025-11-06
Voyant® Open Fusion Device (EB240/Open Fusion) · Applied Medical Resources Corp.510(k) · 2025-11-04
Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) · Applied Medical Resources Corporation510(k) · 2025-10-31
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.