Surgen U
FDA 510(k) K131758 · Pollogen, Ltd.
510(k) numberK131758
Submission
- Device name
- Surgen U
- Applicant
- Pollogen, Ltd.
Washington, DC, US - Received
- June 17, 2013
- Decision date
- December 18, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K242227 | Geneo X ElitePAY · Traditional | 10/12/2025SE |
| K252576 | Legend X PlatformGEI · Special | 09/12/2025SE |
| K250734 | OptiLUV DevicePBX · Traditional | 09/10/2025SE |
| K243217 | Legend X Desktop SystemGEI · Traditional | 11/01/2024SE |
| K240999 | Legend X Applicator VOGEI · Traditional | 05/08/2024SE |
| K233766 | Geneo X ElitePAY · Special | 05/07/2024SE |
| K232903 | Legend X PlatformGEI · Traditional | 10/17/2023SE |
| K220322 | Pollogen STOP U Model UXV DevicePAY · Traditional | 05/04/2023SE |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm TipsGEI · Special | 02/17/2022SE |
| K200545 | Legend Pro DMANGX · Traditional | 10/21/2021SE |
Questions and answers
When was Surgen U cleared by the FDA?
Surgen U (K131758) received a 510(k) decision of Substantially Equivalent on December 18, 2013, 184 days after the submission was received.
What is the product code of K131758?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.