Microline Surgical, Inc.
Microline Surgical, Inc. holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2024, with 7 FDA device recalls on record.
Top product codes for Microline Surgical, Inc.
FDA recalls by Microline Surgical, Inc.
- Z-0663-2025 — Microscissor Tip (Disposable); Microline Catalog #: 3122.
- Z-1698-2019 — TLS2 Thermal Ligating Shears, Catalog Number 132-131D
- Z-1741-2018 — ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
- Z-1740-2018 — ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
- Z-0507-2018 — The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
- Z-1986-2014 — Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
- Z-1987-2014 — Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Microline Surgical, Inc.
- K234147 — ReNew XR Handpiece, 25cm, with Reference Markings (3943M) +5 more
- K213127 — ReNew Disposable Scissor Tips
- K201884 — ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm
- K160706 — ReNew V Handpiece Laparoscopic Instruments
- K152745 — ReNew Sterilization Trays(Catalog #3708 and #3709)
- K152743 — M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
- K124029 — MICROLINE FLEXIBLE LIGATING SHEARS
- K122086 — THERMAL LIGATING SHEARS
Data sourced from openFDA. This site is unofficial and independent of the FDA.