510(k) K012129
- Device
- ORTHO DEVELOPMENT ORION-I EMF SYSTEM
- Applicant
- ORTHO DEVELOPMENT CORP.
- 510(k) number
- K012129
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-22
- Date received
- 2001-07-09
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- CAROL FREASIER
- Address
- 106 W. 12200 S. Draper UT US 84020 84020
FDA Registration Numbers#
- 1051614
- 3029972466
- 3007593903
- 3015497424
- 3013247477
- 3021192541
- 1062741
- 1720747
- 8010273
- 2518897
- 3007728276
- 1057358
- 3028977843
- 3003537036
- 1000523114
- 3002806603
- 2029015
- 3007535734
- 3004601121
- 3009555600
- 9681129
- 3016248634
- 3011944170
- 3006266622
- 3007047889
- 3008864603
- 3014931612
- 3006985163
- 3005110411
- 3011625895
- 3004837686
- 8043746
- 3004111573
- 3002808148
- 3033589330
- 3043226252
- 3043532708
- 3022626486
- 3008911114
- 3010400367
- 3014635169
- 2087572
- 3012497308
- 9611503
- 3020623326
- 3016087306
- 2434839
- 9610877
- 2523676
- 3011230048
- 2530138
- 3010601984
- 3003072803
- 1825527
- 3032391
- 9613563
- 3010684280
- 3011050570
- 8043396
- 3008595179
- 3010187826
- 3011221476
- 3009166798
- 8040233
- 3004903538
- 3009822485
- 3008085016
- 1218017
- 2242450
- 3006747129
- 8010877
- 3011879048
- 3007748793
- 1828288
- 3004878380
- 3010363436
- 3017450375
- 1222313
- 3027242374
Source Documents#
Other 510(k) Records For Product Code GEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 |
Legacy Summary#
summary
FDA Review#
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