Microline Surgical, Inc
Beverly, MA, US
Microline Surgical, Inc appears in FDA device records in Beverly, MA. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Microline Surgical, Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Starion Instruments510(k), recall
510(k) clearance history
FDA records hold 21 510(k) clearances for Microline Surgical, Inc between 1999 and 2024. The busiest year on record is 2000, with 7. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 7 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2016 | 3 |
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K234147 | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) | GEI | Substantially Equivalent | |
| K213127 | ReNew Disposable Scissor Tips | GEI | Substantially Equivalent | |
| K201884 | ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm | GEI | Substantially Equivalent | |
| K160706 | ReNew V Handpiece Laparoscopic Instruments | GEI | Substantially Equivalent | |
| K152745 | ReNew Sterilization Trays(Catalog #3708 and #3709) | KCT | Substantially Equivalent | |
| K152743 | M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) | KCT | Substantially Equivalent | |
| K124029 | MICROLINE FLEXIBLE LIGATING SHEARS | GEI | Substantially Equivalent | |
| K122086 | THERMAL LIGATING SHEARS | GEI | Substantially Equivalent | |
| K070871 | STARION UNIVERSAL POWER SUPPLY | HQO | Substantially Equivalent | |
| K062257 | STARION INSTRUMENTS THERMAL LITIGATING SHEARS | GEI | Substantially Equivalent | |
| K050308 | THERMAL CAUTERY PROBE | HQR | Substantially Equivalent | |
| K043155 | STARION UNIVERSAL POWER SUPPLY (UPS) | HQO | Substantially Equivalent | |
| K002547 | STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR | HQP | Substantially Equivalent | |
| K001273 | STARION INSTRUMENTS POWER POINT CAUTERY CLAMP | GEI | Substantially Equivalent | |
| K001262 | THERMAL CAUTERY FORCEPS | GEI | Substantially Equivalent | |
| K000893 | AC POWERED THERMAL CAUTERY UNIT | HQO | Substantially Equivalent | |
| K000296 | STARION CAUTERY HOOK | GEI | Substantially Equivalent | |
| K000250 | CAUTERY FORCEPS WITH FOOTSWITCH | GEI | Substantially Equivalent | |
| K994019 | CAUTERY GRASPER/DISSECTOR | HQP | Substantially Equivalent | |
| K992460 | CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY | GEI | Substantially Equivalent | |
| K990728 | THERMAL CAUTERY DEVICE, FORCEPS | HQP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1223422 | 1000137656 | Microline Surgical, Inc | 50 Dunham Rd, BEVERLY, MA 01915 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered
- FZPClip, Implantable
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GCJLaparoscope, General & Plastic Surgery
- NWVLaparoscopic Accessories, Gynecologic
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- HQOUnit, Cautery, Thermal, Ac-Powered
- HQPUnit, Cautery, Thermal, Battery-Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0663-2025 | Microscissor Tip (Disposable); Microline Catalog #: 3122. | A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off. | Class II | Open, Classified | |
| Z-1698-2019 | TLS2 Thermal Ligating Shears, Catalog Number 132-131D | The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures. | Class II | Terminated | |
| 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. | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. | Class II | Terminated | |
| 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. | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. | Class II | Terminated | |
| 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. | The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure. | Class II | Terminated | |
| Z-1987-2014 | Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222 | Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw | Class II | Terminated | |
| Z-1986-2014 | Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 | Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw | Class II | Terminated | |
| Z-1635-2014 | Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula. | Grasper jaw may break when force is applied to the jaw | Class II | Terminated | |
| Z-3086-2011 | Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip Ref: 3642 The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula | Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled as 3262 (Long Fenestrated Grasper | Terminated | ||
| Z-3085-2011 | Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip Ref: 3262 The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula | Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled as 3262 (Long Fenestrated Grasper | Terminated | ||
| Z-2239-2010 | The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting of natural or synthetic, non-metallic, sutures during surgery. | The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indicating the device is 'on". | Terminated | ||
| Z-1972-2010 | Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery. | Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use. | Terminated | ||
| Z-1969-2010 | Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting of natural or synthetic, non-metallic sutures during surgery. | Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain