AESCULAP, INC.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2916714	2916714	AESCULAP, INC.	1	Y	2026-01-01	3773 CORPORATE PKWY. CENTER VALLEY PA US 18034
3003587896	3003587896	AESCULAP, INC.	1	N	2026-01-01	615 LAMBERT POINTE DR. HAZELWOOD MO US 63042

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
38731	1533105702	K992218	DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601	GEI	1999-07-30
38732	1533105702	K992218	DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601	GEI	1999-07-30
38731	1095310300	K992053	AESCULAP VASCULAR INSTRUMENTS	DXC	2000-01-13
38732	1095310300	K992053	AESCULAP VASCULAR INSTRUMENTS	DXC	2000-01-13
38732	1007212069	K991088	VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE	JKA	1999-05-28
38731	1007212069	K991088	VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE	JKA	1999-05-28
38732	2042786639	K984124	AESCULAP XENON LIGHT SOURCE	FSS	1999-02-01
38731	2042786639	K984124	AESCULAP XENON LIGHT SOURCE	FSS	1999-02-01
38732	1389241055	K983758	YASARGIL TITANIUM ANEURYSM CLIPS	HCH	1998-12-18
38731	1389241055	K983758	YASARGIL TITANIUM ANEURYSM CLIPS	HCH	1998-12-18
38731	1573602567	K983365	AESCULAP MINOP SYSTEM	GWG	1998-12-18
38732	1573602567	K983365	AESCULAP MINOP SYSTEM	GWG	1998-12-18
38732	1024479295	K982914	AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS	MNI	1998-10-02
38731	1024479295	K982914	AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS	MNI	1998-10-02
38732	1062122835	K982623	AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM	GCJ	1998-09-30
38731	1062122835	K982623	AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM	GCJ	1998-09-30
38732	1525399471	K981645	TITANIUM HEMOSTATIC CLIP	FZP	1998-10-13
38731	1525399471	K981645	TITANIUM HEMOSTATIC CLIP	FZP	1998-10-13
38732	1584843244	K980686	AESCULAP HILAN MOTOR SYSTEM	HBB	1998-09-02
38731	1584843244	K980686	AESCULAP HILAN MOTOR SYSTEM	HBB	1998-09-02
38732	2009986050	K974382	ACKERMANN SURGICAL INSTRUMENTS	GCJ	1998-04-21
38731	2009986050	K974382	ACKERMANN SURGICAL INSTRUMENTS	GCJ	1998-04-21
38732	1349818049	K973736	AESCULAP HILAN MOTOR SYSTEM	HWE	1997-12-29
38731	1349818049	K973736	AESCULAP HILAN MOTOR SYSTEM	HWE	1997-12-29
38732	1891975118	K972332	AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM	GXN	1998-01-16
38731	1891975118	K972332	AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM	GXN	1998-01-16
38732	1225445746	K971310	AESCULAP JET IRRIGATION SYSTEM	GEI	1997-07-18
38731	1225445746	K971310	AESCULAP JET IRRIGATION SYSTEM	GEI	1997-07-18
38732	1980057081	K970851	LYOPLANT DURA SUBSTITUTE(VARIOUS)	GXQ	1997-12-09
38731	1980057081	K970851	LYOPLANT DURA SUBSTITUTE(VARIOUS)	GXQ	1997-12-09
38731	1549808807	K970541	AESCULAP MODULAR MONOPOLAR ELECTRODES	GEI	1997-03-28
38732	1549808807	K970541	AESCULAP MODULAR MONOPOLAR ELECTRODES	GEI	1997-03-28
38731	1223544689	K970050	YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)	HCH	1997-11-26
38732	1223544689	K970050	YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)	HCH	1997-11-26
38732	1032630538	K964281	AESCULAP ANGLED NEUROENDOSCOPES	GWG	1997-04-21
38731	1032630538	K964281	AESCULAP ANGLED NEUROENDOSCOPES	GWG	1997-04-21
38732	1260348330	K960470	NEURO-PATCH	GXQ	1996-05-10
38731	1260348330	K960470	NEURO-PATCH	GXQ	1996-05-10
38731	1034411667	K954652	AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS	HRX	1996-02-14
38732	1034411667	K954652	AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS	HRX	1996-02-14
38732	1253257511	K953968	AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)	HWE	1996-02-05
38731	1253257511	K953968	AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)	HWE	1996-02-05
38732	1328441970	K953446	AESCULAP BIPOLAR CORDS	GEI	1995-09-29
38731	1328441970	K953446	AESCULAP BIPOLAR CORDS	GEI	1995-09-29
38732	1382243351	K952524	AESCULAP BIOPOLAR COAGULATOR	GEI	1995-06-29
38731	1382243351	K952524	AESCULAP BIOPOLAR COAGULATOR	GEI	1995-06-29
38732	1397462915	K944955	AESCULAP THORACOSCOPIC INSTRUMENTS	KNS	1994-11-09
38731	1397462915	K944955	AESCULAP THORACOSCOPIC INSTRUMENTS	KNS	1994-11-09
38732	1916985015	K944864	PRIMED RIGID CONTAINER SYSTEM	KCT	1994-12-20
38731	1916985015	K944864	PRIMED RIGID CONTAINER SYSTEM	KCT	1994-12-20
38731	1286039765	K944467	AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS	GCJ	1994-10-03
38732	1286039765	K944467	AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS	GCJ	1994-10-03
38732	1735260422	K942730	AESCULAP LAPAROSCOPES	HET	1995-04-25
38731	1735260422	K942730	AESCULAP LAPAROSCOPES	HET	1995-04-25
38731	1799137746	K942053	AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SET	GCJ	1994-06-10
38732	1799137746	K942053	AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SET	GCJ	1994-06-10
38732	1309715916	K940970	YASARGIL, CASPAR, VARIO CLIP APPLIERS	HCI	1995-01-24
38731	1309715916	K940970	YASARGIL, CASPAR, VARIO CLIP APPLIERS	HCI	1995-01-24
38732	1611466112	K940936	AESCULAP ENDOSCOPIC INSTRUMENTS	GEI	1994-04-19
38731	1611466112	K940936	AESCULAP ENDOSCOPIC INSTRUMENTS	GEI	1994-04-19
38732	1455388961	K935243	AESCULAP FLEXIBLE TROCAR INSTRUMENT SET	GCJ	1994-07-21
38731	1455388961	K935243	AESCULAP FLEXIBLE TROCAR INSTRUMENT SET	GCJ	1994-07-21
38732	1018171076	K934724	AESCULAP TROCAR INSTRUMENT SET	FBQ	1993-12-23
38731	1018171076	K934724	AESCULAP TROCAR INSTRUMENT SET	FBQ	1993-12-23
38732	1706079571	K933330	AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS	GCJ	1994-06-07
38731	1706079571	K933330	AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS	GCJ	1994-06-07
38732	1227606012	K933076	AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS	GCJ	1993-09-10
38731	1227606012	K933076	AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS	GCJ	1993-09-10
38732	1277565756	K922797	AESCULAP TROCAR INSTRUMENT SET	GCJ	1993-03-30
38731	1277565756	K922797	AESCULAP TROCAR INSTRUMENT SET	GCJ	1993-03-30
38732	1096448136	K922576	AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS	GEI	1993-06-10
38731	1096448136	K922576	AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS	GEI	1993-06-10
38732	1072610644	K922272	YASARGIL ANEURYSM CLIPS	HCH	1992-09-15
38731	1072610644	K922272	YASARGIL ANEURYSM CLIPS	HCH	1992-09-15
38732	1566193287	K913765	YASARGIL ANEURYSM CLIPS, MODIFICATION	HCH	1992-03-11
38731	1566193287	K913765	YASARGIL ANEURYSM CLIPS, MODIFICATION	HCH	1992-03-11
38732	2025589734	K913514	ELECTROSURGICAL UNIT CABLE	GEI	1991-11-05
38731	2025589734	K913514	ELECTROSURGICAL UNIT CABLE	GEI	1991-11-05
38731	1871365997	K900533	DISPOSABLE BIPOLAR COAGULATING FORCEPS	GEI	1990-04-09
38732	1871365997	K900533	DISPOSABLE BIPOLAR COAGULATING FORCEPS	GEI	1990-04-09
38731	1839334227	K890765	STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GAS	JOJ	1989-08-07
38731	1788415039	K890443	CASPAR SCALP CLIP, APPLIER	HBO	1989-06-15
38732	1788415039	K890443	CASPAR SCALP CLIP, APPLIER	HBO	1989-06-15
38732	1575959068	K884057	ELAN-E DISPOSABLE DRAPE	KKX	1988-10-19
38731	1575959068	K884057	ELAN-E DISPOSABLE DRAPE	KKX	1988-10-19
38732	1945138848	K880704	CERULLO SUCTION REGULATOR	GCX	1988-03-29
38731	1945138848	K880704	CERULLO SUCTION REGULATOR	GCX	1988-03-29
38732	1847697133	K833652	YASARGIL FENESTRATED ANEURYSM CLIP &	HCH	1984-01-27
38731	1847697133	K833652	YASARGIL FENESTRATED ANEURYSM CLIP &	HCH	1984-01-27
38731	1946640825	K833651	CLIP APPLYING FORCEPS	HCI	1983-11-29
38732	1946640825	K833651	CLIP APPLYING FORCEPS	HCI	1983-11-29
38732	1771793209	K833650	YASARGIL STANDARD ANEURYSM CLIP &	HCH	1984-01-18
38731	1771793209	K833650	YASARGIL STANDARD ANEURYSM CLIP &	HCH	1984-01-18
38732	1565017685	K831236	BIPOLAR CARD	GEI	1983-06-02
38731	1565017685	K831236	BIPOLAR CARD	GEI	1983-06-02
38732	1130879005	K811820	BIPOLAR COAGULATING FORCEPS	GEI	1981-07-28
38731	1130879005	K811820	BIPOLAR COAGULATING FORCEPS	GEI	1981-07-28
38732	1216311662	K792558	CONTAINER SYSTEM	FLE	1979-12-27
38731	1216311662	K792558	CONTAINER SYSTEM	FLE	1979-12-27
38732	1282791256	K770428	VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC.	FSM	1979-09-12
38731	1282791256	K770428	VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC.	FSM	1979-09-12
38731	1918807171	K242003	XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set	JXG	2024-12-16
38731	2032510429	K223596	SQ.line KERRISON	HAE	2023-06-29
38731	1702287626	K211572	Aesculap Slim Clip Applier	HCI	2021-12-13
38731	1763140735	K203739	ELAN 4 Electro Motor System	HBE	2021-08-24
38731	1630177293	K203461	Aesculap Caiman 12 Seal and Cut Technology System	GEI	2020-12-18
38731	1321934999	K202391	DIR 800	IZI	2021-01-21
38731	1607321878	K200950	Ventricular Catheter	JXG	2020-05-08
38731	1898022869	K193582	SterilContainer S2 System	KCT	2020-03-17
38732	1898022869	K193582	SterilContainer S2 System	KCT	2020-03-17
38732	1232621912	K192266	M. Blue Adjustable Shunt System	JXG	2019-11-21
38731	1232621912	K192266	M. Blue Adjustable Shunt System	JXG	2019-11-21
38732	1766723949	K192056	JJ Series Container System	KCT	2020-03-27
38731	1766723949	K192056	JJ Series Container System	KCT	2020-03-27
38732	1077028169	K190811	Optimus NEURO System - Sterile Kit	GWO	2019-11-27
38731	1077028169	K190811	Optimus NEURO System - Sterile Kit	GWO	2019-11-27
38731	1344369484	K190174	Miethke Shunt System GAV 2.0 and SA 2.0 Valves	JXG	2019-07-05
38732	1344369484	K190174	Miethke Shunt System GAV 2.0 and SA 2.0 Valves	JXG	2019-07-05
38731	1762621311	K183352	Optimus Neuro System	GWO	2019-01-02
38732	1762621311	K183352	Optimus Neuro System	GWO	2019-01-02

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
GEI	47	2020-12-18
GCJ	25	2018-02-20
JXG	24	2024-12-16
KCT	22	2020-03-27
HCH	22	2014-01-24
FZP	13	2010-08-06
FRG	12	2010-07-27
GWG	10	2014-11-14
HCI	9	2021-12-13
HBE	9	2021-08-24
GWO	6	2019-11-27
HBC	6	2016-07-22
GXQ	6	2013-06-04
GXN	6	2012-08-30
HAW	6	2008-05-23
HAE	5	2023-06-29
HBB	4	2018-11-09
HCZ	4	2018-05-08
GZT	4	2016-09-09
DXC	4	2012-04-30
GXR	4	2010-08-12
HBO	4	2001-07-31
HRX	4	2001-04-27
HWE	4	1997-12-29
JOJ	3	2014-11-24
HIF	3	2011-08-19
KNF	3	2001-06-11
JOF	2	2017-12-27
DWP	2	2017-06-29
MAI	2	2007-04-30
JDQ	2	2006-12-27
HAD	2	2006-11-21
JEY	2	2006-04-07
JWH	2	2002-11-08
HBI	2	2002-09-06
HCA	2	2002-04-05
GWM	2	2001-06-28
MNH	2	2001-04-11
HGI	2	2001-02-20
MTJ	2	2000-03-24