510(k) K172580
- Device
- ENSEAL X1 Tissue Sealer, Straight Jaw, 25 Cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 Cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 Cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 Cm Shaft Length,ENSEAL X1 Tissue Sea
- Applicant
- Ethicon Endo-Surgery, LLC
- 510(k) number
- K172580
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-20
- Date received
- 2017-08-28
- 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
- Carmen Ortiz
- Address
- 475 Calle C Guaynabo PR US 00969 00969
FDA Registration Numbers#
- 3004044817
- 3014279513
- 3007029079
- 3007185216
- 3021477808
- 8040537
- 3021519357
- 3007710878
- 3008720584
- 3015806723
- 3006716777
- 1526534
- 9680721
- 3010402752
- 3015460875
- 3013858269
- 3013557681
- 3008849319
- 9613563
- 3010380518
- 3005809810
- 3030626857
- 3011120183
- 3033715699
- 3010377594
- 3007748817
- 3009486890
- 3007583504
- 3007024186
- 3013652305
- 2087572
- 3007960282
- 3012606445
- 1211998
- 8043746
- 3010202439
- 3013551587
- 3036803067
- 3002250546
- 3006849754
- 3010621964
- 3011586151
- 1063285
- 3004837686
- 8010047
- 3004483538
- 3007305485
- 1123137
- 3012497308
- 3013886523
- 9611612
- 9611112
- 3014579161
- 3008114965
- 3010155648
- 9610617
- 3014262693
- 3007535734
- 3016851379
- 3008889904
- 3027645761
- 2020394
- 3012204368
- 3009513193
- 1054811
- 3011987935
- 3006555617
- 3011944170
- 2184009
- 2435119
- 3010188783
- 3013875599
- 1221826
- 3007748793
- 3017196117
- 3015192261
- 9680340
- 1060680
- 3009555600
Source Documents#
Other 510(k) Records For Product Code GEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026-06-02 |
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 |
| 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 |
Legacy Summary#
summary
FDA Review#
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