510(k) K211579
- Device
- CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
- Applicant
- Bolder Surgical, LLC
- 510(k) number
- K211579
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-07
- Date received
- 2021-05-21
- 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
- Nicholas Wong
- Address
- 331 S. 104th St. Suite 200 Louisville CO US 80027 80027
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 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 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 | OsteoCoolâ„¢ RF Ablation System; OsteoCoolâ„¢ 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 |