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MICROLINE 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
LinkedIn: —
Facebook: —
Email: [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)

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Device	Model / Reference	Registries	Class	Status
ReNew	3908	FDA UDI	Class II	Active
Gemini	1133L	FDA UDI	Class II	Unknown
ReNew Disposable Tenaculum Tip (5mm)	3392	FDA UDI	Class II	Active
ReNew	3504TA	FDA UDI	Class II	Active
ReNew	3202	FDA UDI	Class II	Active
ReNew	3515TA	FDA UDI	Class II	Active
ReNew	3291	FDA UDI	Class II	Active
ReNew	3252	FDA UDI	Class II	Active
ReNew	3910	FDA UDI	Class II	Active
ReNew	3141	FDA UDI	Class II	Active
ReNew XR Handpiece with Reference Length Markings	3944M	FDA UDI	Class II	Active
ReNew XR Handpiece with Reference Length Markings	3945M	FDA UDI	Class II	Active
ReNew	3914	FDA UDI	Class II	Active
ReNew	3332	FDA UDI	Class II	Active
MiSeal	152-101R	FDA UDI	Class II	Unknown
ReNew	3232	FDA UDI	Class II	Active
M/L-10	1002R	FDA UDI	Class II	Unknown
ReNew XR Handpiece with Reference Length Markings	3946M	FDA UDI	Class II	Active
ReNew XR	3530	FDA UDI	Class II	Active
ReNew	3242	FDA UDI	Class II	Active
Microline	132-136D	FDA UDI	Class II	Active
ReNew	3471	FDA UDI	Class II	Active
ReNew	3472	FDA UDI	Class II	Active
Gemini	1113L	FDA UDI	Class II	Unknown
ReNew	1042	FDA UDI	Class II	Active
ReNew	3112	FDA UDI	Class II	Active
ReNew	3918	FDA UDI	Class II	Active
M/L-10	1122J	FDA UDI	Class II	Active
ReNew	3292	FDA UDI	Class II	Active
ReNew	6902	FDA UDI	Class II	Active
ReNew	3342	FDA UDI	Class II	Active
ReNew	3652	FDA UDI	Class II	Active
ReNew	3151	EUDAMEDFDA UDI	Class II	Active
MiSeal	152-103R	FDA UDI	Class II	Unknown
ReNew XR Handpiece with Reference Length Markings	3942M	FDA UDI	Class II	Active
ReNew Sterilization Trays(Catalog #3708 and #3709)	K152745	FDA 510(k)	Class II	Active
Thermal Ligating Shears	K122086	FDA 510(k)	Class II	Active
ReNew V Handpiece Laparoscopic Instruments	K160706	FDA 510(k)	Class II	Active
Microline Flexible Ligating Shears	K124029	FDA 510(k)	Class II	Active
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)	K234147	FDA 510(k)	Class II	Active
M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)	K152743	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
ReNew Disposable Scissor Tips	K213127	FDA 510(k)	Class II	Active
Renew XR Handpiece, Ratcheted, 34cm	3944	EUDAMEDFDA UDI	Class IIa	Active
Renew XR Handpiece, 34cm	3941	EUDAMEDFDA UDI	Class IIa	Active
Reveel	RV093001	EUDAMEDFDA UDI	Class IIa	Active
Renew XR Handpiece, Ratcheted, 42cm	3945	EUDAMEDFDA UDI	Class IIa	Active
M/L-10 Sterilization Tray	3706	EUDAMEDFDA UDI	Class I	Active
Reveel	RT083001	EUDAMEDFDA UDI	Class IIa	Active
Renew XR Handpiece 25cm	3943	EUDAMEDFDA UDI	Class IIa	Active
Renew XR Handpiece, 42cm	3942	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

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Notified Bodies

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Authorities

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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