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Unimicro Medical Systems (shenzhen) Co., Ltd.: FDA-registered device maker in ShenZhen Guangdong, China, 5 510(k) clearances

Name: Unimicro Medical Systems (shenzhen) Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Unimicro Medical Systems (shenzhen) Co., Ltd. is registered with the FDA (registration 3010806467) in ShenZhen Guangdong, China. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 10, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010806467
Address: 101, 201, 301, Bldg 38,Xialang Industrial Area,Heshuikou, Matian Street, Guangming District, ShenZhen Guangdong, China, 518106
Owner or operator: Unimicro Medical Systems (Shenzhen) Co., Ltd. (10046262)
Roles: Manufacturer
First device listed: February 25, 2014
Registered through: 2026
Brand names listed: Auto Retrieval Pouch, Insufflation Tubing Set, Monopolar Laparoscopic Accessories, Smoke Filter, Suction Irrigation Set, Suction Irrigation Set with Smoke Filter, Trocar Kit ATR Series, BTR Series, VTR Series, HTR Series, STR Series, UNTR Series, UNTB Series, 1TR Series, Veress Needle MND11200, MND11500

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Pneumoperitoneum Needle	FHO	2	Manufacturer	accessdata.fda.gov
Tube, Smoke Removal, Endoscopic	FCZ	1	Manufacturer	accessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, Laparoscopic	NKC	1	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
August 10, 2015	K141594	Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar	GCJ	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov
July 31, 2015	K150068	Unimicro Veress Needle	HIF	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov
April 13, 2015	K142208	Monopolar Laparascopic Accessories	GEI	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov
November 13, 2014	K141593	UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH	GCJ	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov
August 4, 2014	K141592	UNIMICRO SUCTION IRRIATION TUBING SET	GCJ	Substantially Equivalent	Unimicro Medical Systems (Shenzhen) Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 10, 2015. 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.