Kapp Surgical GmbH

Cleveland, OH, US

KAPP SURGICAL GMBH appears in FDA device records in Cleveland, OH. FDA records list 9 510(k) clearances between 1984-09-12 and 2021-01-28, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 9
PMA records: 0
Recall records: 2
Registered establishments: 2

FDA records under these names

1 name

FDA records resolved to Kapp Surgical GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Kapp Surgical Instrument, Inc.510(k), recall

510(k) clearance history

FDA records hold 9 510(k) clearances for Kapp Surgical GmbH between 1984 and 2021. The busiest year on record is 1984, with 2. The most recent is 2021, with 1.

Clearances by year, as a table

510(k) clearance decisions for Kapp Surgical GmbH, by decision year
Year	Clearances
1984	2
2003	1
2004	1
2005	2
2006	1
2007	1
2021	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K200289	Michler-Kapp Cardiovascular Vent Catheter	DWF	Substantially Equivalent	2021-01-28
K072216	KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536	NEU	Substantially Equivalent	2007-11-09
K050384	KAPP BARI-RING, MODEL KS-BR-2005	NEU	Substantially Equivalent	2006-01-13
K050657	MONDEAL CONTOUR HO SYSTEM	HRS	Substantially Equivalent	2005-08-08
K050655	MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005	HRS	Substantially Equivalent	2005-08-08
K033930	KAPP CUSTOM ULNAR HEAD WRIST IMPLANT	KXE	Substantially Equivalent	2004-07-28
K030237	KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT	KWI	Substantially Equivalent	2003-08-29
K844177	COSGROVE MITRAL VALVE RETRACTOR	GAD	Substantially Equivalent	1984-11-08
K843368	KAPP SPINAL BUTTON	HTN	Substantially Equivalent	1984-09-12

Registered establishments

FDA registered establishments for Kapp Surgical GmbH, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
8010769	7282	KAPP SURGICAL GMBH	5. HAUPTSTRASSE, DUERBHEIM Baden-Wurttemberg D-78589 DE	2026	DWS EFL EIG EJY EKD EMG EMH EMJ EMM FCL and 34 more, listed in full below
1522875	1522875	KAPP SURGICAL, INC.	4919 Warrensville Center Rd, Cleveland, OH 44128 US	2026	DWS DXC FFP FZO GAD GDG GDJ GDZ GEA GEN and 13 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2753-2011	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 then placed into a solid white box. Item is shipped and sold non-sterile. It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.	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.		2011-05-24	Terminated
Z-0068-2012	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 shipping container. The Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.	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.		2008-03-05	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain