Data / Medical devices / United States / Kapp Surgical, Inc.

Kapp Surgical, Inc.: FDA-registered device maker in Cleveland, OH, United States, 2 510(k) clearances

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

Kapp Surgical, Inc. is registered with the FDA (registration 1522875) in Cleveland, OH, United States. It lists 23 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 28, 2004. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1522875
Address: 4919 Warrensville Center Rd, Cleveland, OH, United States, 44128
Owner or operator: KAPP SURGICAL, INC. (1522875)
Roles: Manufacturer, Specification developer
First device listed: February 13, 1989
Registered through: 2026
Brand names listed: 9-17mm Reamer, Adult Renal, Ankeney Sternal Retractor, Baby Renal, Bariatric, Beven Aorta Aneurysm Clamp, Bone Forcep for Bankart, Bulldog and more

Devices it lists

Device	Product code	Class	Role	Source
Awl	HWJ	1	Manufacturer	accessdata.fda.gov
Blade, Scalpel	GES	1	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Manufacturer	accessdata.fda.gov
Clamp, Carotid Artery	HCE	2	Manufacturer	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Manufacturer	accessdata.fda.gov
Clamp, Vascular	DXC	2	Manufacturer	accessdata.fda.gov
Dilator, Rectal	FFP	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Manufacturer	accessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, Polymer	KWI	2	Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Wrist, Hemi-, Ulnar	KXE	2	Manufacturer, Specification developer	accessdata.fda.gov
Rasp	HTR	1	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Manufacturer	accessdata.fda.gov
Template	HWT	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
July 28, 2004	K033930	KAPP CUSTOM ULNAR HEAD WRIST IMPLANT	KXE	Substantially Equivalent	Kapp Surgical Instrument, Inc.	accessdata.fda.gov
August 29, 2003	K030237	KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT	KWI	Substantially Equivalent	Kapp Surgical Instrument, 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
May 24, 2011	59024	Not yet classified	Terminated	Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is t	During an FDA Inspection on 3/21/11 - 3/22/11 at Kapp Surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions contained in the device master record. Kapp Surgical decided to conduct the recall because we cannot be sure that incorrect instructions were not shipped.	accessdata.fda.gov
March 5, 2008	60000	Not yet classified	Terminated	STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box is placed into a shipp	A portion of the labeled expiration date is missing. The expiration date on approximately half of the pouch labels distributed are missing the last digit of the year of expiration. However, the shelf box containing the pouches is labeled correctly.	accessdata.fda.gov

Compare with other makers

Updated July 7, 2011. 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.