Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
FDA 510(k) clearance K150538 · decided 2015-06-25
Clearance details
- K-number
- K150538
- Device name
- Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
- Applicant
- Stryker Sustainability Solutions
- Decision
- Substantially Equivalent
- Date received
- 2015-03-03
- Decision date
- 2015-06-25
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- NUJ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (K232511) | Surgical Instrument Service and Savings, Inc. | 2024-04-29 |
| Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (K230251) | Stryker Sustainability Solutions | 2023-03-28 |
| Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (K220411) | Stryker Sustainability Solutions | 2022-05-13 |
| Green OR Reprocessed Aquamantys Bipolar Sealer (K211203) | Green Or, LLC | 2022-04-07 |
| Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (K191073) | Vein 360, LLC | 2019-10-22 |
| Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider (K182588) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2018-10-31 |
| Reprocessed LigaSure Maryland Jaw Sealer/Divider (K180499) | Stryker Sustainability Solutions | 2018-04-23 |
| Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (K180451) | Stryker Sustainability Solutions | 2018-04-20 |
| NES Reprocessed RF Stylet (RFS) (K173214) | Northeast Scientific, Inc. (Nes) | 2018-03-27 |
| Reprocessed DePuy Mitek Ablation Wand (K173740) | Renovo, Inc. | 2018-03-19 |
| Reprocessed ArthoCare Ablation Wand (K173741) | Renovo, Inc. | 2018-03-05 |
| Reprocessed ArthroCare ENT Coblator (K172647) | Renovo, Inc. | 2018-02-21 |
Recalls involving this device
No recalls on record reference this clearance.