Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
FDA 510(k) K182588 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren
510(k) numberK182588
Submission
- Device name
- Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
- Applicant
- Surgical Instrument Service and Savings Inc.(Dba Medline Ren
Redmond, OR, US - Received
- September 20, 2018
- Decision date
- October 31, 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 |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ · Traditional | Stryker Sustainability Solutions | 04/23/2018SE |
| 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 |
|---|---|---|
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…NLH · Traditional | 11/15/2024SE |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 ShearsNLQ · Traditional | 08/19/2020SE |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional | 07/03/2017SE |
| K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerNUJ · Traditional | 05/02/2016SE |
| K151617 | Livewire Electrophysiology CatheterNLH · Traditional | 01/22/2016SE |
Questions and answers
When was Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider cleared by the FDA?
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider (K182588) received a 510(k) decision of Substantially Equivalent on October 31, 2018, 41 days after the submission was received.
What is the product code of K182588?
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.