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I.C. Medical, Inc.: FDA-registered device maker in Phoenix, AZ, United States, 8 510(k) clearances

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

I.C. Medical, Inc. is registered with the FDA (registration 3008805497) in Phoenix, AZ, United States. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 30, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008805497
Address: 15002 N. 25th Dr. --, Phoenix, AZ, United States, 85023
Owner or operator: I.C. MEDICAL, INC. (9000161)
Roles: Manufacturer
First device listed: November 8, 2007
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Exhaust, Surgical	FYD	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	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
October 30, 2017	K163659	Crystal Vision	FYD	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov
April 5, 2016	K160160	Non-Telescopic PenEvac	GEI	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov
October 7, 1995	K953418	ELECTROCAUTERY SHROUD	GCJ	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov
September 22, 1995	K954088	TELESCOPING PENEVAC	GEI	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov
February 18, 1994	K932230	CRYSTAL VISION AND ACCESSORIES	FYD	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov
July 28, 1993	K930098	SPECULUM SMOKE EVACUATOR TUBING	GEX	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov
February 12, 1992	K914118	I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR	FYD	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov
August 17, 1990	K902611	I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR	FYD	Substantially Equivalent	I.C Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 30, 2017. 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.