Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1522875

FEI Number

1522875

Entity Name

KAPP SURGICAL INSTRUMENT, INC.

City/State/Country

Bedford Heights, OH, US

Establishment Address

4919 WARRENSVILLE CENTER RD., Bedford Heights, OH 44128, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KAPP SURGICAL INSTRUMENT, INC. (Owner Number: 1522875)

Owner / Operator Contact Address

4919 WARRENSVILLE CENTER RD., --, WARRENSVILLE HEIGHTS, OH 44128, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KAPP CUSTOM ULNAR Michler-Kapp Cardiovascular Vent Cathter MTF Impactor Hip Impactor Liberty Mallots Staple Impactor Modified Javid Clamps Chisel KAPP CVT SUCTION STABILIZER Coned Heparin Needles KAPP CUSTOM RADIAL MTF Trial IMOBILIZER IKI KAPP KNEE BRACE KISS INTRA-OPERATIVE KNEE Baby Renal Humphries Aorta Aneurysm Clamp Loop Aorta Clamp Bulldog Beven Aorta Aneurysm Clamp Adult Renal Martinez Clamp Coolen Sternum Retractor McCarthy Retractor Cosgrove Mitral Valve Retractor Ankeney Sternal Retractor IMA Mammary Retractor Knee Retractor Reosenkranz Retractor Gillanov Hand Held Maze Retractor Bariatric Ptosis Clamp Vasectomy S&L Awl Seitz Swl MTF Tamp MTF Inserter STRIP-T'S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2006-01-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2021-04-19
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-01-31
HCE	Clamp, Carotid Artery	Neurology	Class 2	882.5175	2020-11-17
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2013-01-31
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2002-09-04
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-31
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2006-01-31
HWT	Template	Orthopedic	Class 1	888.4800	2023-12-01
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	1989-02-13
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2020-11-17
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1989-02-13
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-31
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-01-31
HXG	Tamp	Orthopedic	Class 1	888.4540	2023-12-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2023-12-01
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2002-09-04

Official Correspondent

ALBERT SANTILLI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KAPP SURGICAL INSTRUMENT, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0005-2023	Wright Medical Technology, Inc.	2	stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1522875. Last updated year: 2026. Please use registration number 1522875 when referencing this establishment in official correspondence.