510(k) K141587
- Device
- E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER
- Applicant
- MEGADYNE MEDICAL PRODUCTS, INC.
- 510(k) number
- K141587
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-02-18
- Date received
- 2014-06-13
- 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
- RONDA MAGNESON
- Address
- 11506 S. State St. Draper UT US 84020 84020
FDA Registration Numbers#
- 3014848720
- 9710524
- 3010131137
- 3012322232
- 3010291427
- 3004122598
- 3006849754
- 9614641
- 3013783488
- 1319639
- 3011070163
- 3010280625
- 1223422
- 3023155873
- 1221541
- 1000121056
- 8040233
- 8010591
- 3009882464
- 3009762450
- 3009051888
- 9681191
- 3010331645
- 1216677
- 1317547
- 3047841690
- 3015225571
- 3027339877
- 3008933393
- 9613563
- 3015460875
- 3017450375
- 8010312
- 3007544634
- 3001614464
- 3019269298
- 3012507533
- 3004044817
- 3009241989
- 3014262693
- 1724474
- 3013700547
- 3008085016
- 3013505638
- 3024021261
- 9616696
- 3013077751
- 2320762
- 3016438694
- 3004483538
- 8030607
- 3013438730
- 3007699067
- 3039167637
- 3006789154
- 3008720584
- 2133810
- 3027267119
- 3038675429
- 1056350
- 3010701628
- 9611612
- 9680515
- 3033715699
- 2529846
- 3014023545
- 1721983
- 3011063460
- 9614434
- 9611827
- 3023706404
- 3008753275
- 3012510750
- 3004777218
- 3004519921
- 1923569
- 9680718
- 3003678543
- 3010353867
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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