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#
- 3014579024
- 3001675293
- 3010739934
- 1424263
- 3030495752
- 1824037
- 3030446844
- 3010131466
- 3006142527
- 3004060780
- 3040335671
- 3035374386
- 3017448139
- 2954783
- 3007014520
- 3004111573
- 1926681
- 1526012
- 2431166
- 3010511300
- 1056128
- 2126666
- 3002808227
- 3010188783
- 3020968442
- 3020163307
- 3030230686
- 3008040402
- 3045753434
- 3041276883
- 3019751610
- 3006515340
- 3008102042
- 3022626486
- 2916714
- 3012510750
- 3017262662
- 3007499195
- 1319660
- 3004784537
- 3017210488
- 9681383
- 3009881188
- 1418975
- 3013500228
- 3014579161
- 1929938
- 3017196117
- 3010041511
- 3013176080
- 1722040
- 3009217531
- 3010356635
- 3015542154
- 3015531529
- 3006498370
- 8043746
- 3006747129
- 3027339877
- 1319639
- 2246552
- 2649622
- 1222780
- 3013563737
- 1221826
- 3008824097
- 3012582478
- 3007137643
- 3030153385
- 3008837339
- 3004754983
- 2647580
- 3005334138
- 3038988287
- 9613793
- 3009732568
- 1720747
- 9610849
- 3003782610
Source Documents#
Other 510(k) Records For Product Code GEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 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 |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 |
Legacy Summary#
summary
FDA Review#
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