510(k) K172610
- Device
- THUNDERBEAT 5 Mm, 20 Cm, Front-actuated Grip Type S, THUNDERBEAT 5 Mm, 35 Cm, Front-actuated Grip Type S, THUNDERBEAT 5 Mm, 45 Cm, Front-actuated Grip Type S
- Applicant
- Olympus Medical Systems Corp.
- 510(k) number
- K172610
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-17
- Date received
- 2017-08-31
- 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
- Toshiyuki Nakajima
- Address
- 2951 Ishikawa-Cho Hachioji-Shi JP 192-8507 192-8507
FDA Registration Numbers#
- 3021192541
- 8030967
- 3045010542
- 3002808022
- 3011120183
- 3008915316
- 3013557562
- 3005369776
- 3007305485
- 1061124
- 1060680
- 3009903460
- 3006451981
- 3006696607
- 3012639025
- 3011277660
- 3042953831
- 3010157088
- 3011063460
- 3015539532
- 3005857264
- 3007829657
- 3009822485
- 3014193078
- 1030489
- 3007014520
- 3032109
- 1032347
- 3014982808
- 3013820501
- 1527736
- 2133936
- 3012204368
- 3027454635
- 3044777128
- 3014579024
- 3010363436
- 3004638532
- 3013602304
- 3008215723
- 3007648309
- 3010380518
- 9614279
- 2024311
- 3029916132
- 1037007
- 1225798
- 3003455467
- 3017262662
- 3017202975
- 1221826
- 9680660
- 8040537
- 3010806467
- 3007024186
- 9612278
- 3014663814
- 3015231789
- 3010836847
- 8010591
- 1000523114
- 3009746061
- 3006561161
- 2433012
- 1423537
- 3010353867
- 1720747
- 3015460875
- 3004601121
- 8010312
- 3008102042
- 2244478
- 9616675
- 3011989678
- 2182536
- 3006636961
- 3010684280
- 3014980461
- 3012757453
Source Documents#
Other 510(k) Records For Product Code GEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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