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Sign in to claim this brandMICROLINE SURGICAL, INC.
United States·US-MF-000009811
Last updated May 24, 2026
What MICROLINE SURGICAL, INC. makes
Microline Surgical, Inc. manufactures reusable and single-use endoscopic electrosurgical tools, including monopolar handpieces and electrodes, as well as rigid and flexible endoscopic scissors and tissue manipulation forceps. Their portfolio also includes metallic ligation clips designed for endoscopic procedures. The company produces reusable and disposable versions of these instruments, alongside electrosurgical power systems for use in surgical settings.
The company’s devices are classified under EU regulations as Class I or Class II/IIa, with corresponding authorisations through the FDA’s 510(k) and UDI programs. Their products are registered in the EU’s eudamed database, ensuring compliance with both U.S. and European medical device regulations. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Microline Surgical, Inc. manufacture?
Microline Surgical, Inc. specializes in endoscopic electrosurgical tools, including monopolar reusable handpieces and electrodes, as well as rigid and flexible endoscopic scissors and forceps for tissue manipulation. Their portfolio also covers metallic ligation clips, with options for both single-use and reusable versions. These devices are designed for surgical procedures requiring precision and control, such as minimally invasive surgeries.
Where is Microline Surgical, Inc. based, and how does that affect its regulatory compliance?
Microline Surgical, Inc. is headquartered in the United States. As a U.S.-based manufacturer, its devices must comply with both FDA regulations (such as 510(k) clearance and UDI requirements) and EU regulations (e.g., Class I or Class II/IIa classifications). The company registers its devices in the FDA’s 510(k) and UDI systems, as well as the EU’s eudamed database, ensuring adherence to both markets’ regulatory frameworks.
Which regulatory registries list Microline Surgical, Inc.’s devices, and why is this important?
Microline Surgical, Inc.’s devices are listed in the EU’s eudamed database, the FDA’s 510(k) clearance registry, and the FDA’s UDI (Unique Device Identification) system. Inclusion in these registries demonstrates compliance with mandatory reporting requirements in both the U.S. and EU, ensuring transparency for healthcare providers, regulators, and patients. For example, eudamed is required for EU market surveillance, while FDA registries support traceability and post-market monitoring.
How are Microline Surgical, Inc.’s devices classified under EU and FDA regulations?
Under EU regulations, Microline Surgical, Inc.’s devices fall into Class I (low-risk, often exempt from strict pre-market controls) or Class II/IIa (moderate-risk, requiring additional safety assessments). In the U.S., their devices are cleared via the FDA’s 510(k) pathway, which compares them to a legally marketed predicate device, while the UDI system ensures standardized identification for tracking. Classification depends on factors like invasiveness, risk of harm, and intended use, as defined by both regulatory bodies.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 50, Dunham Road, Beverly, United States
- Website
- www.microlinesurgical.com
- —
- —
- [email protected]
- Phone
- +1 978 922 9810
- PRRC Contact
- Scott Marchand Davis
- EUDAMED SRN
- US-MF-000009811
- FDA FEI Number
- —
- DUNS Number
- 184080570
Catalogue (150)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ReNew | 3241 | FDA UDI | Class II | Active |
| ReNew | 3311 | FDA UDI | Class II | Active |
| ReNew | 3401 | FDA UDI | Class II | Active |
| Microline | 200-004R | FDA UDI | Class II | Unknown |
| ReNew | 3351 | FDA UDI | Class II | Active |
| ReNew | 3431 | FDA UDI | Class II | Active |
| ReNew | 3162 | FDA UDI | Class II | Active |
| ReNew | 3122 | FDA UDI | Class II | Active |
| ReNew | 3918R | FDA UDI | Class II | Unknown |
| ReNew | 3925R | FDA UDI | Class II | Unknown |
| ReNew | 63-09-00 | FDA UDI | Class II | Active |
| ReNew | 3272 | FDA UDI | Class II | Active |
| ReNew | 3915R | FDA UDI | Class II | Unknown |
| Visu-Loc | 2001 | FDA UDI | Class II | Unknown |
| ReNew | 3935R | FDA UDI | Class II | Unknown |
| ReNew | 3352 | FDA UDI | Class II | Active |
| ReNew | 6925 | FDA UDI | Class II | Active |
| MiSeal | 452-131D | FDA UDI | Class II | Unknown |
| ReNew | 3201 | FDA UDI | Class II | Active |
| ReNew XR Handpiece with Reference Length Markings | 3943M | FDA UDI | Class II | Active |
| ReNew | 63-08-00 | FDA UDI | Class II | Active |
| ReNew | 3905 | FDA UDI | Class II | Active |
| ReNew | 3908R | FDA UDI | Class II | Unknown |
| ReNew | 3222 | FDA UDI | Class II | Active |
| ReNew Disposable Tenaculum Tip (10mm) | 3422 | FDA UDI | Class II | Active |
| ReNew | 3514TA | FDA UDI | Class II | Active |
| ReNew | 3312 | FDA UDI | Class II | Active |
| ReNew | 6924 | FDA UDI | Class II | Active |
| M/L-10 | 1112 | FDA UDI | Class II | Active |
| ReNew | 3302 | FDA UDI | Class II | Active |
| ReNew | 3321 | FDA UDI | Class II | Active |
| M/L-10 | 1112J | FDA UDI | Class II | Active |
| ReNew | 3924R | FDA UDI | Class II | Unknown |
| ReNew | 6162 | FDA UDI | Class II | Active |
| ReNew | 3281 | FDA UDI | Class II | Active |
| ReNew | 3221 | FDA UDI | Class II | Active |
| ReNew | 3381 | FDA UDI | Class II | Active |
| ReNew | 3271 | FDA UDI | Class II | Active |
| ReNew | 3914R | FDA UDI | Class II | Unknown |
| ReNew XR | 3533 | FDA UDI | Class II | Active |
| ReNew | 3632 | FDA UDI | Class II | Active |
| Microline | 100-006D | FDA UDI | Class II | Active |
| ReNew | 3251 | FDA UDI | Class II | Active |
| ReNew | 3402 | FDA UDI | Class II | Active |
| ReNew | 3505TA | FDA UDI | Class II | Active |
| ReNew | 6182 | FDA UDI | Class II | Active |
| ReNew XR Handpiece with Reference Length Markings | 3941M | FDA UDI | Class II | Active |
| Microline | 132-131D | FDA UDI | Class II | Unknown |
| ReNew | 3904 | FDA UDI | Class II | Active |
| Microline | 132-134D | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
MicroLine Surgical, Inc. has ten recall records initiated between July 18, 2011, and November 5, 2024, with statuses including open, classified, and terminated. The reasons cited involve mislabeling of product numbers for specific graspers, potential insulation failure during sterilization, structural weaknesses such as jaw breakage in graspers and scissors, compromised sterile barriers in laparoscopic instrument tips, and functional failures in shears, including actuation malfunctions.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 5, 2024 | Z-0663-2025 | — | open, classified | A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off. |
| Mar 22, 2019 | Z-1698-2019 | — | terminated | 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. |
| Nov 1, 2017 | Z-1741-2018 | — | terminated | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. |
| Nov 1, 2017 | Z-1740-2018 | — | terminated | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. |
| Jul 13, 2017 | Z-0507-2018 | — | terminated | 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. |
| May 12, 2014 | Z-1987-2014 | — | terminated | Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw |
| May 12, 2014 | Z-1986-2014 | — | terminated | Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw |
| Apr 14, 2014 | Z-1635-2014 | — | terminated | Grasper jaw may break when force is applied to the jaw |
| Jul 18, 2011 | Z-3086-2011 | — | terminated | 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 |
| Jul 18, 2011 | Z-3085-2011 | — | terminated | 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 |