Data / Medical devices / Japan / Mani, Inc. (head Office)

Mani, Inc. (head Office): FDA-registered device maker in UTSUNOMIYA Tochigi, Japan, 4 510(k) clearances

Name: Mani, Inc. (head Office) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mani, Inc. (head Office) is registered with the FDA (registration 3002692886) in UTSUNOMIYA Tochigi, Japan. It lists 20 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 19, 2006. 3 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 Mani, Inc. (head Office)

FDA registration number: 3002692886
Address: 8-3, Kiyohara Industrial Park, UTSUNOMIYA Tochigi, Japan, 321-3231
Owner or operator: MANI, INC. (HEAD OFFICE) (8030343)
Roles: Contract manufacturer, Manufacturer
First device listed: October 1, 1981
Registered through: 2026
Brand names listed: Crescent, Double Step - Angled 1 mm, FINGER PLUGGER, FINGER SPREADER, Gates Drills, Golf/Scleral, JIZAI GLIDER, MANI CARBIDE BURS and more

Devices it lists

Device	Product code	Class	Role	Source
Blade, Scalpel	GES	1	Manufacturer	accessdata.fda.gov
Broach, Endodontic	EKW	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Cannula, Trocar, Ophthalmic	NGY	1	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Manufacturer	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Manufacturer	accessdata.fda.gov
Knife, Ent	KTG	1	Manufacturer	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Manufacturer	accessdata.fda.gov
Needle, Suturing, Reusable	GDL	1	Manufacturer	accessdata.fda.gov
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	PAW	2	Contract manufacturer	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Manufacturer	accessdata.fda.gov
Reamer, Pulp Canal, Endodontic	EKP	1	Manufacturer	accessdata.fda.gov
Spreader, Pulp Canal Filling Material, Endodontic	EKK	1	Manufacturer	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	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
May 19, 2006	K053638	MANI NEEDLE & SUTURE PACK (SILK)	GAP	Substantially Equivalent	Mani, Inc.	accessdata.fda.gov
May 19, 2006	K053637	MANI NEEDLE & SUTURE PACK (NYLON)	GAR	Substantially Equivalent	Mani, Inc.	accessdata.fda.gov
March 14, 2006	K053636	MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)	GAM	Substantially Equivalent	Mani, Inc.	accessdata.fda.gov
December 5, 2005	K050150	MANI NEEDLE & SUTURE PACK	GAT	Substantially Equivalent	Mani, 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
February 20, 2023	91829	Class II	Terminated	Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.	A packaging defect may compromise the sterile barrier.	accessdata.fda.gov
October 27, 2020	86873	Class II	Terminated	MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S	Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use	accessdata.fda.gov
July 20, 2011	60225	Not yet classified	Terminated	MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Indus	Surgical sutures may be weak and may not function as intended during surgical procedures.	accessdata.fda.gov

Compare with other makers

Updated April 26, 2023. 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.