Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k) K260636 · Stryker Sustainability Solutions
510(k) numberK260636
Submission
- Device name
- Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
- Applicant
- Stryker Sustainability Solutions
Tempe, AZ, US - Received
- February 26, 2026
- Decision date
- June 18, 2026
- 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 |
| 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 |
| K253634 | CoolSeal Generator® (CSL-200-90)GEI · Traditional | Hologic, Inc. | 06/17/2026SE |
More from Hologic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…NLQ · Traditional | 08/14/2025SE |
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…NLF · Traditional | 10/22/2024SE |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special | 07/03/2024SE |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional | 02/20/2024SE |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031)OWQ · Special | 07/25/2023SE |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019GEI · Special | 03/28/2023SE |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Special | 03/28/2023SE |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…NLF · Traditional | 12/04/2022SE |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)GEI · Traditional | 05/25/2022SE |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Traditional | 05/13/2022SE |
Questions and answers
When was Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating cleared by the FDA?
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (K260636) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 112 days after the submission was received.
What is the product code of K260636?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.