Reprocessed LigaSure Maryland Jaw Sealer/Divider
FDA 510(k) K180499 · Stryker Sustainability Solutions
510(k) numberK180499
Submission
- Device name
- Reprocessed LigaSure Maryland Jaw Sealer/Divider
- Applicant
- Stryker Sustainability Solutions
Tempe, AZ, US - Received
- February 26, 2018
- Decision date
- April 23, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUJ – Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Other 510(k)s with product code NUJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)NUJ · Traditional | Surgical Instrument Service and Savings, Inc. | 04/29/2024SE |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Special | Stryker Sustainability Solutions | 03/28/2023SE |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Traditional | Stryker Sustainability Solutions | 05/13/2022SE |
| K211203 | Green OR Reprocessed Aquamantys Bipolar SealerNUJ · Traditional | Green Or, LLC | 04/07/2022SE |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterNUJ · Traditional | Vein 360, LLC | 10/22/2019SE |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 10/31/2018SE |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/DividerNUJ · Traditional | Stryker Sustainability Solutions | 04/20/2018SE |
| K173214 | NES Reprocessed RF Stylet (RFS)NUJ · Traditional | Northeast Scientific, Inc. (Nes) | 03/27/2018SE |
| K173740 | Reprocessed DePuy Mitek Ablation WandNUJ · Traditional | Renovo, Inc. | 03/19/2018SE |
| K173741 | Reprocessed ArthoCare Ablation WandNUJ · Traditional | Renovo, Inc. | 03/05/2018SE |
More from Renovo, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | 06/18/2026SE |
| 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 |
Questions and answers
When was Reprocessed LigaSure Maryland Jaw Sealer/Divider cleared by the FDA?
Reprocessed LigaSure Maryland Jaw Sealer/Divider (K180499) received a 510(k) decision of Substantially Equivalent on April 23, 2018, 56 days after the submission was received.
What is the product code of K180499?
The FDA product code is NUJ – Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 878.4400.