510(k) K081954
- Device
- GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE
- Applicant
- GYRUS ACMI, INC.
- 510(k) number
- K081954
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-31
- Date received
- 2008-07-09
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERRENCE E SULLIVAN
- Address
- 136 Tpke. Rd. Southborough MA US 01772 01772
FDA Registration Numbers#
- 3003935342
- 1222140
- 3015974593
- 3026606306
- 3005075853
- 3001431138
- 3010687973
- 3019569846
- 3007421149
- 1418975
- 3012453745
- 9614279
- 3009736547
- 1319639
- 3004940677
- 3010885402
- 3014004349
- 3029754081
- 3011683674
- 1223422
- 1222993
- 3010164891
- 3007748793
- 3010361165
- 8040510
- 3005646850
- 3010684280
- 8040537
- 3016678045
- 1421879
- 1423537
- 3000268902
- 3009183442
- 3006017180
- 9610617
- 3003767927
- 3012783431
- 3011024991
- 3036773433
- 3008264458
- 3012818475
- 3012616488
- 2521453
- 9710058
- 3030412764
- 1412854
- 2133936
- 3003418325
- 3011063460
- 2084346
- 3003072803
- 3012428212
- 3013700547
- 2183613
- 8030607
- 3016813690
- 3004837686
- 3002808022
- 3011559089
- 3003687489
- 3042272797
- 8010418
- 3017892510
- 3045753434
- 3013176080
- 3002808227
- 3013789508
- 2087572
- 3013820501
- 1061124
- 3015151147
- 3030626857
- 3006950086
- 3015286855
- 3006897899
- 3016555232
- 3016607092
- 8010298
- 3042940623
Source Documents#
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 |
Legacy Summary#
summary
FDA Review#
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