Microline Surgical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 8
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0663-2025 | Class II | Microscissor Tip (Disposable); Microline Catalog #: 3122. | November 5, 2024 |
| Z-1698-2019 | Class II | TLS2 Thermal Ligating Shears, Catalog Number 132-131D | March 22, 2019 |
| Z-1740-2018 | Class II | ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew | November 1, 2017 |
| Z-1741-2018 | Class II | ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single | November 1, 2017 |
| Z-0507-2018 | Class II | The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces | July 13, 2017 |
| Z-1986-2014 | Class II | Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 | May 12, 2014 |
| Z-1987-2014 | Class II | Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222 | May 12, 2014 |
| Z-1635-2014 | Class II | Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReN | April 14, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K234147 | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference | April 23, 2024 |
| K213127 | ReNew Disposable Scissor Tips | March 2, 2022 |
| K201884 | ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratch | October 21, 2020 |
| K160706 | ReNew V Handpiece Laparoscopic Instruments | October 19, 2016 |
| K152745 | ReNew Sterilization Trays(Catalog #3708 and #3709) | May 12, 2016 |
| K152743 | M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) | February 8, 2016 |
| K124029 | MICROLINE FLEXIBLE LIGATING SHEARS | March 27, 2013 |
| K122086 | THERMAL LIGATING SHEARS | August 23, 2012 |