LAP-iX
FDA 510(k) K200639 · Sejong Medical Co., Ltd.
510(k) numberK200639
Submission
- Device name
- LAP-iX
- Applicant
- Sejong Medical Co., Ltd.
Paju-Si, CN - Received
- March 10, 2020
- Decision date
- September 29, 2021
- 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).
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| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
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| 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 |
|---|---|---|
| K253165 | LAP-iX2NGEI · Traditional | 06/09/2026SE |
| K252985 | LaportGCJ · Traditional | 05/19/2026SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | 04/03/2020SE |
| K173108 | SmokleanFYD · Traditional | 05/18/2018SE |
| K173111 | LAP-iX Suction IrrigationHET · Traditional | 11/28/2017SE |
| K173112 | LAP-iXGEI · Traditional | 11/21/2017SE |
| K171726 | LapBagGCJ · Traditional | 09/25/2017SE |
| K171741 | LaportGCJ · Traditional | 08/29/2017SE |
Questions and answers
When was LAP-iX cleared by the FDA?
LAP-iX (K200639) received a 510(k) decision of Substantially Equivalent on September 29, 2021, 568 days after the submission was received.
What is the product code of K200639?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.