Data / Medical devices / United States / Cytophil, Inc

Cytophil, Inc: FDA-registered device maker in East Troy, WI, United States, 4 510(k) clearances

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

Cytophil, Inc is registered with the FDA (registration 3007225376) in East Troy, WI, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 6, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007225376
Address: 2485 Corporate Circle, Unit 2, East Troy, WI, United States, 53120
Owner or operator: Cytophil, Inc (10025827)
Roles: Contract manufacturer, Manufacturer
First device listed: February 15, 2011
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Bone Grafting Material, Synthetic	LYC	2	Manufacturer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
System, Vocal Cord Medialization	MIX	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
April 6, 2015	K150400	Renu Gel	MIX	Substantially Equivalent	Cytophil, Inc.	accessdata.fda.gov
February 22, 2013	K121795	CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT	MIX	Substantially Equivalent	Cytophil, Inc.	accessdata.fda.gov
December 27, 2010	K102937	OSTEOPHIL BETA-TCP	MQV	Substantially Equivalent	Cytophil, Inc.	accessdata.fda.gov
April 22, 2010	K093871	PERIOPHIL B-TCP	LYC	Substantially Equivalent	Cytophil, 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
January 11, 2012	61044	Not yet classified	Terminated	Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc. Model #03002-01: Perio	Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic because devices were inadvertently shipped after receiving an inadequate dose of radiation and this product may not be sterile.	accessdata.fda.gov

Compare with other makers

Updated April 6, 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.