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#
- 2184009
- 1221934
- 3013176080
- 9680952
- 3003678543
- 3009380063
- 3009881188
- 2245590
- 2431166
- 3006849754
- 2029275
- 3004111573
- 2133786
- 3009882464
- 3013283620
- 3012447612
- 3007710878
- 2648623
- 3004122598
- 3015612252
- 3010280625
- 1929938
- 3012497308
- 3009762450
- 3010288205
- 3012322232
- 3018242561
- 1836161
- 2020394
- 1222993
- 3006891627
- 9610614
- 2955842
- 3011879048
- 3013466775
- 2032098
- 3004636440
- 3012790575
- 9614969
- 3007583504
- 3040335671
- 3009420598
- 3010164891
- 3017892510
- 3019569846
- 2434839
- 8030607
- 9611827
- 2248148
- 8043746
- 3018126215
- 3014479313
- 3022320321
- 3005467144
- 3013944123
- 3020623326
- 3027988352
- 3007748817
- 3004519921
- 2024024
- 3009736547
- 3016496662
- 3017450375
- 3030839824
- 3006696607
- 3006404071
- 3012818475
- 3015542154
- 2182291
- 3015779311
- 2124215
- 1526611
- 9614279
- 3007007790
- 3031571464
- 2183715
- 8030967
- 1000523114
- 3008915316
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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