Data / Medical devices / United States / Microline Surgical, Inc

Microline Surgical, Inc: FDA-registered device maker in Beverly, MA, United States, 18 510(k) clearances

Name: Microline Surgical, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Microline Surgical, Inc is registered with the FDA (registration 1223422) in Beverly, MA, United States. It lists 6 device types. The FDA files 18 510(k) clearances under its listings, the newest dated April 23, 2024. 10 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Microline Surgical, Inc

FDA registration number: 1223422
FEI number: 1000137656
Address: 50 Dunham Rd, Beverly, MA, United States, 01915
Owner or operator: MICROLINE SURGICAL, INC. (9006317)
Roles: Complaint file establishment, Manufacturer
First device listed: January 24, 2007
Registered through: 2026
Brand names listed: REVEEL, ReNew Disposable Scissor Tips, ReNew XR Handpiece, ReNew XR Handpiece with Reference Length Markings, Ten Comfort Disposable Scope Warmer

Devices it lists

Device	Product code	Class	Role	Source
Clip, Implantable	FZP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Laparoscopic Accessories, Gynecologic	NWV	1	Complaint file establishment	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Unit, Cautery, Thermal, Ac-Powered	HQO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 23, 2024	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	Microline Surgical, Inc.	accessdata.fda.gov
March 2, 2022	K213127	ReNew Disposable Scissor Tips	GEI	Substantially Equivalent	Microline Surgical, Inc.	accessdata.fda.gov
October 21, 2020	K201884	ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm	GEI	Substantially Equivalent	Microline Surgical, Inc.	accessdata.fda.gov
April 29, 2019	K190592	YelloPort Elite Port Access System	GCJ	Substantially Equivalent	Surgical Innovations Limited	accessdata.fda.gov
May 12, 2016	K152745	ReNew Sterilization Trays(Catalog #3708 and #3709)	KCT	Substantially Equivalent	Microline Surgical, Inc.	accessdata.fda.gov
February 8, 2016	K152743	M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)	KCT	Substantially Equivalent	Microline Surgical, Inc.	accessdata.fda.gov
April 11, 2014	K133345	REVEEL ENDOSCOPIC RETRACTOR	GCJ	Substantially Equivalent	Retraction Limited	accessdata.fda.gov
August 23, 2012	K122086	THERMAL LIGATING SHEARS	GEI	Substantially Equivalent	Microline Surgical, Inc.	accessdata.fda.gov
April 13, 2007	K070871	STARION UNIVERSAL POWER SUPPLY	HQO	Substantially Equivalent	Starion Instruments	accessdata.fda.gov
March 28, 2007	K070712	MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM	GCJ	Substantially Equivalent	Surgical Innovations Group Plc	accessdata.fda.gov
October 10, 2006	K062257	STARION INSTRUMENTS THERMAL LITIGATING SHEARS	GEI	Substantially Equivalent	Starion Instruments	accessdata.fda.gov
December 18, 2003	K033161	VISU-LOCK 5MM CLIP APPLIER	FZP	Substantially Equivalent	Gyrx, LLC	accessdata.fda.gov
January 8, 2002	K013695	MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10	GCJ	Substantially Equivalent	Microline Pentax, Inc.	accessdata.fda.gov
March 7, 2000	K000250	CAUTERY FORCEPS WITH FOOTSWITCH	GEI	Substantially Equivalent	Starion Instruments	accessdata.fda.gov
May 29, 1998	K981389	DISPOSABLE RE-NEW FORCEPS	GEI	Substantially Equivalent	Microline Pentax, Inc.	accessdata.fda.gov
May 20, 1998	K981188	ELECTROSURGICAL CAUTERY PROBES	GEI	Substantially Equivalent	Microline Pentax, Inc.	accessdata.fda.gov
January 22, 1998	K974066	RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS	GEI	Substantially Equivalent	Microline Pentax, Inc.	accessdata.fda.gov
August 9, 1996	K962119	RE-NEW LAPAROSCOPIC INSTRUMENTS	GEI	Substantially Equivalent	Microline Pentax, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 5, 2024	95734	Class II	Ongoing	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.	accessdata.fda.gov
March 22, 2019	82708	Class II	Terminated	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.	accessdata.fda.gov
November 1, 2017	79435	Class II	Terminated	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 cuttin	Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.	accessdata.fda.gov
July 13, 2017	78754	Class II	Terminated	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 surgi	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.	accessdata.fda.gov
May 12, 2014	68495	Class II	Terminated	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	accessdata.fda.gov
April 14, 2014	68012	Class II	Terminated	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,	Grasper jaw may break when force is applied to the jaw	accessdata.fda.gov
July 18, 2011	59469	Not yet classified	Terminated	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, incl	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	accessdata.fda.gov
March 9, 2010	55043	Not yet classified	Terminated	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 surg	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".	accessdata.fda.gov
June 26, 2008	55750	Not yet classified	Terminated	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 c	Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.	accessdata.fda.gov
February 6, 2008	55721	Not yet classified	Terminated	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 cutti	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.	accessdata.fda.gov

Compare with other makers

Updated December 10, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.