KARL STORZ ENDOSCOPY-AMERICA, INC.

Matched from indexed company URL: KARL STORZ ENDOSCOPY

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2020550	2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	1	Y	2026-01-01	28 Millbury Street Auburn MA US 01501
3010202439	3007475226	Karl Storz Endoscopy-America, Inc.	1	N	2026-01-01	2151 E. Grand Avenue El Segundo CA US 90245

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
9059	1187711881	P050027	KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM	OAY	2010-05-28
153846	1187711881	P050027	KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM	OAY	2010-05-28
9059	1363062866	P020008	KARL STORZ AUTOFLUORESCENCE SYSTEM	MRK	2002-12-12
153846	1363062866	P020008	KARL STORZ AUTOFLUORESCENCE SYSTEM	MRK	2002-12-12
9059	1328769044	K994348	KSEA SCB-RUI	FET	2000-03-03
153846	1328769044	K994348	KSEA SCB-RUI	FET	2000-03-03
9059	1220067449	K994090	KARL STORZ AUTOCLAVABLE CAMERA HEAD	FET	2000-02-04
153846	1220067449	K994090	KARL STORZ AUTOCLAVABLE CAMERA HEAD	FET	2000-02-04
9059	1437536328	K994066	MTP DISPOSABLE TROCARS	GCJ	2000-01-20
153846	1437536328	K994066	MTP DISPOSABLE TROCARS	GCJ	2000-01-20
9059	1684109392	K993804	KSEA RIGID CULDOSCOPE AND ACCESSORIES	HEW	2000-02-07
153846	1684109392	K993804	KSEA RIGID CULDOSCOPE AND ACCESSORIES	HEW	2000-02-07
9059	1635027265	K993540	ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE	HRX	1999-11-22
153846	1635027265	K993540	ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE	HRX	1999-11-22
9059	1326822406	K993539	DCI ENDOSCOPE	GWG	1999-12-15
153846	1326822406	K993539	DCI ENDOSCOPE	GWG	1999-12-15
9059	1997484813	K992541	LAPAROCAM	GCJ	1999-08-19
153846	1997484813	K992541	LAPAROCAM	GCJ	1999-08-19
9059	1154228894	K992469	KSEA SCBCOM	FET	1999-10-15
153846	1154228894	K992469	KSEA SCBCOM	FET	1999-10-15
9059	1286927784	K992114	KSEA CALCUSPLIT	FFK	1999-08-18
153846	1286927784	K992114	KSEA CALCUSPLIT	FFK	1999-08-18
9059	1096997605	K992027	KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR	HIH	1999-09-09
153846	1096997605	K992027	KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR	HIH	1999-09-09
9059	1866964722	K991592	KSEA DE LA PLAZA BLEPHAROPLASTY SET	HNI	1999-11-02
153846	1866964722	K991592	KSEA DE LA PLAZA BLEPHAROPLASTY SET	HNI	1999-11-02
9059	1188871716	K991228	DCI ENDOSCOPE	GCJ	1999-06-23
153846	1188871716	K991228	DCI ENDOSCOPE	GCJ	1999-06-23
9059	1179579596	K991171	DCI ENDOSCOPE	GCJ	1999-06-23
153846	1179579596	K991171	DCI ENDOSCOPE	GCJ	1999-06-23
9059	1894027558	K991069	KSEA NEURO-FIBERSCOPE	GWG	1999-06-03
153846	1894027558	K991069	KSEA NEURO-FIBERSCOPE	GWG	1999-06-03
9059	1492443883	K991051	KSEA EPIDUROSCOPE	HRX	1999-06-01
153846	1492443883	K991051	KSEA EPIDUROSCOPE	HRX	1999-06-01
9059	1040415091	K990912	MTP EXTRACTION BAG	GCJ	1999-06-09
153846	1040415091	K990912	MTP EXTRACTION BAG	GCJ	1999-06-09
9059	1534559620	K990911	MTP ARTHROPUMP DISPOSABLE TUBING SET	HRX	1999-06-03
153846	1534559620	K990911	MTP ARTHROPUMP DISPOSABLE TUBING SET	HRX	1999-06-03
9059	1380378288	K990910	MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS	HIH	1999-06-03
153846	1380378288	K990910	MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS	HIH	1999-06-03
153846	1030116969	K990909	MTP UROPUMP DISPOSABLE TUBING SET	LJH	1999-06-09
9059	2016253126	K990411	MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE	HIH	1999-05-11
153846	2016253126	K990411	MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE	HIH	1999-05-11
9059	1275019469	K990334	KSEA ENDOSCOPE HOLDER	OCV	1999-03-22
153846	1275019469	K990334	KSEA ENDOSCOPE HOLDER	OCV	1999-03-22
9059	1176309441	K990154	KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM	FWF	1999-06-01
153846	1176309441	K990154	KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM	FWF	1999-06-01
9059	1416318165	K990004	DCI ENDOSCOPE	HET	1999-04-02
153846	1416318165	K990004	DCI ENDOSCOPE	HET	1999-04-02
9059	1043123071	K984369	DCI ENDOSCOPE	EOB	1999-01-29
153846	1043123071	K984369	DCI ENDOSCOPE	EOB	1999-01-29
9059	1390747445	K983901	KSEA HF-SNARE	HIH	1999-02-01
153846	1390747445	K983901	KSEA HF-SNARE	HIH	1999-02-01
9059	2058040104	K983569	KSEA MONOPOLAR VAPORIZATION ELECTRODES	HIH	1999-01-08
153846	2058040104	K983569	KSEA MONOPOLAR VAPORIZATION ELECTRODES	HIH	1999-01-08
9059	1039553237	K983384	DCI ENDOSCOPE	HRX	1998-11-25
153846	1039553237	K983384	DCI ENDOSCOPE	HRX	1998-11-25
9059	1675491070	K983363	DCI ENDOSCOPE	GCJ	1998-12-18
153846	1675491070	K983363	DCI ENDOSCOPE	GCJ	1998-12-18
9059	1624661876	K983142	KSEA C-MOUNT ARTHROSCOPES	HRX	1998-12-07
153846	1624661876	K983142	KSEA C-MOUNT ARTHROSCOPES	HRX	1998-12-07
9059	1105584220	K982905	MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE	FGB	1998-10-05
153846	1105584220	K982905	MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE	FGB	1998-10-05
9059	1693712505	K982837	KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS	GWG	1998-11-06
153846	1693712505	K982837	KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS	GWG	1998-11-06
9059	1116143390	K982658	KSEA ENDOSCOPES FOR DENTAL PROCEDURES	EIA	1998-10-15
153846	1116143390	K982658	KSEA ENDOSCOPES FOR DENTAL PROCEDURES	EIA	1998-10-15
9059	1759898687	K982571	KSEA FLIPPTACK	MBI	1998-09-22
153846	1759898687	K982571	KSEA FLIPPTACK	MBI	1998-09-22
9059	1693093236	K981703	KSEA UNIMAT 45	BTA	1998-08-12
153846	1693093236	K981703	KSEA UNIMAT 45	BTA	1998-08-12
9059	1784060643	K981615	KSEA UROPUMP	LJH	1998-07-08
153846	1784060643	K981615	KSEA UROPUMP	LJH	1998-07-08
9059	1711154658	K981458	KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110	EOB	1998-05-20
153846	1711154658	K981458	KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110	EOB	1998-05-20
9059	1335413605	K981233	KSEA CALCUSPLIT	FFK	1998-06-15
153846	1335413605	K981233	KSEA CALCUSPLIT	FFK	1998-06-15
9059	1699265413	K981130	KSEA ENDO TIP SYSTEM	HET	1998-08-19
153846	1699265413	K981130	KSEA ENDO TIP SYSTEM	HET	1998-08-19
9059	1321587462	K980694	KSEA PLASTIC TROCARS	HET	1998-05-08
153846	1321587462	K980694	KSEA PLASTIC TROCARS	HET	1998-05-08
9059	1572556733	K980134	KSEA N2O ENDOFLATOR	HIF	1998-04-15
153846	1572556733	K980134	KSEA N2O ENDOFLATOR	HIF	1998-04-15
9059	1622170203	K974391	KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM	GCJ	1998-01-30
153846	1622170203	K974391	KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM	GCJ	1998-01-30
9059	1981888449	K974366	KSEA PLASTIC TROCARS	GCJ	1998-01-08
153846	1981888449	K974366	KSEA PLASTIC TROCARS	GCJ	1998-01-08
9059	1924435340	K973909	KSEA ENDOTIP SYSTEM	GCJ	1998-02-27
153846	1924435340	K973909	KSEA ENDOTIP SYSTEM	GCJ	1998-02-27
9059	1515902258	K973304	MVM 3.3 MM MICROENDOSCOPE	HET	1997-12-02
153846	1515902258	K973304	MVM 3.3 MM MICROENDOSCOPE	HET	1997-12-02
9059	1062161412	K973252	KARL STORZ DIRECT COUPLED CAMERA HEAD	FET	1997-11-24
153846	1062161412	K973252	KARL STORZ DIRECT COUPLED CAMERA HEAD	FET	1997-11-24
9059	1685973077	K973251	KSEA CALCUSON	FEO	1998-06-22
153846	1685973077	K973251	KSEA CALCUSON	FEO	1998-06-22
9059	1100365937	K973068	KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING	GCJ	1997-11-07
153846	1100365937	K973068	KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING	GCJ	1997-11-07
9059	2064519589	K972926	MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE	FBN	1997-10-08
153846	2064519589	K972926	MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE	FBN	1997-10-08
9059	1658944512	K972855	KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES	EOB	1997-09-08
153846	1658944512	K972855	KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES	EOB	1997-09-08
9059	1494383526	K972504	MVM 3.3 MM MICROENDOSCOPE	GCJ	1997-08-11
153846	1494383526	K972504	MVM 3.3 MM MICROENDOSCOPE	GCJ	1997-08-11
9059	1500533668	K972497	KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES	GEI	1997-08-27
153846	1500533668	K972497	KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES	GEI	1997-08-27
9059	1892470854	K972488	KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES	HET	1998-01-22
153846	1892470854	K972488	KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES	HET	1998-01-22
9059	1621367921	K971982	KARL STORZ MODEL 203020 20 EQUIMAT	LJH	1997-08-12
153846	1621367921	K971982	KARL STORZ MODEL 203020 20 EQUIMAT	LJH	1997-08-12
9059	1046348624	K971977	KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE	FBN	1997-08-12
153846	1046348624	K971977	KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE	FBN	1997-08-12
9059	1781666808	K971649	KSEA ARTHROPUMP PLUS	HRX	1997-10-29
153846	1781666808	K971649	KSEA ARTHROPUMP PLUS	HRX	1997-10-29
9059	1958045793	K971518	KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES	HIH	1997-07-24
153846	1958045793	K971518	KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES	HIH	1997-07-24
9059	1466193389	K970427	KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE	FGB	1997-03-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GCJ	133	2025-11-22
EOB	68	2020-08-11
HRX	68	2010-10-18
HET	63	2015-11-20
FET	38	2022-05-13
FGB	31	2025-11-18
HIH	30	2023-09-14
GEI	29	2017-08-02
EOQ	28	2025-12-05
GWG	24	2018-04-17
HIF	21	2025-09-22
OWN	20	2026-02-26
FAJ	18	2025-08-13
FBO	14	2025-05-02
HIG	14	2020-07-22
EOX	14	2020-01-24
FJL	12	2024-05-07
ERL	12	2020-10-22
LJH	11	2017-07-07
ODA	10	2023-10-03
GEX	9	2023-09-08
KCT	9	2021-07-06
GCT	8	2008-12-18
HWC	8	2007-09-12
OCX	8	2004-04-28
FFK	8	1999-08-18
FBN	8	1997-10-08
KNF	8	1995-02-09
FGA	6	2024-05-01
LLZ	6	2011-12-13
FAS	6	2006-08-21
FTA	6	2005-08-11
HEW	6	2004-02-27
EQJ	6	1995-09-06
EWY	5	2026-03-02
OCV	4	2024-10-22
HIN	4	2013-06-26
FCW	4	2013-01-25
OAY	4	2010-05-28
DXC	4	2002-12-11

PMA#

KARL STORZ D-Light C PDD System

2022-03-17

KARL STORZ ENDOSCOPY-AMERICA, INC.2151 E. Grand Ave.el Segundo, CA 90245 PMA NumberP050027 Supplement NumberS030 Date Received02/16/2022 Decision Date03/17/2022 Product Code OAY Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Suppl...