Oligio X
FDA 510(k) K243929 · Wontech Co., Ltd.
510(k) numberK243929
Submission
- Device name
- Oligio X
- Applicant
- Wontech Co., Ltd.
64, Techno 8-Ro, Yuseong-Gu, KR - Received
- December 20, 2024
- Decision date
- January 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K252877 | SANDRO DualGEX · Traditional | 12/19/2025SE |
| K250165 | PastelleGEX · Traditional | 07/03/2025SE |
| K251288 | VeincareGEX · Special | 05/14/2025SE |
| K251094 | Alma VeilGEX · Special | 05/06/2025SE |
| K243957 | PicoalexGEX · Traditional | 03/12/2025SE |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)GEX · Traditional | 02/14/2025SE |
| K241527 | Pastelle ProGEX · Traditional | 02/14/2025SE |
| K241930 | VeincareGEX · Traditional | 11/14/2024SE |
| K241406 | LavieenGEX · Traditional | 06/28/2024SE |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY)GEX · Traditional | 06/24/2024SE |
Questions and answers
When was Oligio X cleared by the FDA?
Oligio X (K243929) received a 510(k) decision of Substantially Equivalent on January 21, 2025, 32 days after the submission was received.
What is the product code of K243929?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.