SYNERGETICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1932402	1000119053	SYNERGETICS, INC.	1	Y	2026-01-01	3845 Corporate Centre Dr O Fallon MO US 63368

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
45717	1296176715	K993039	VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)	MRH	2000-01-07
45717	1441928156	K982212	VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010	GEI	1998-12-02
45717	1487060838	K955346	VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM	GEI	1995-12-08
45717	1076830561	K954308	GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE	HQB	1995-12-22
45717	1045610561	K954307	GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE	HQB	1995-12-22
45717	1666097928	K954306	GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE	HQB	1995-12-22
45717	1815818218	K952586	GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR	MPA	1995-09-01
45717	1918758908	K952585	GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR	MPA	1996-01-05
45717	1206052192	K952584	GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK	MPA	1995-09-01
45717	1498542732	K952569	GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR	HQR	1996-01-05
45717	1257992413	K951985	PRECISION BIPOLAR COAGULATOR	GEI	1995-05-23
45717	1921544209	K950287	UNIVIT PROBE	HKP	1995-04-10
45717	1013626954	K932668	OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER	HQE	1994-02-23
45717	1168842862	K890648	MALIS BIPOLAR CORD/IRRIGATION TUBING SET	GEI	1989-03-03
45717	1194911436	K121675	VERSAVIT	HQE	2012-06-21
45717	1842556265	K121426	AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS	GEI	2012-07-10
45717	1043048539	K113857	SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE	HQB	2012-04-23
45717	1504745421	K110924	DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS	GEI	2011-12-07
45717	1865280621	K091441	SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET	FRN	2009-10-30
45717	1600478362	K032598	SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE	MPA	2003-11-24
45717	1888571198	K020220	ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE	LFL	2002-08-23
45717	1281864318	K010309	SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR	LFL	2001-04-18
45717	1026487838
45717	1123312964
45717	1152802408
45717	1223867462
45717	1534006619
45717	1459385787
45717	1538794938
45717	1634187620
45717	1696182130
45717	1752059615
45717	1794556318
45717	1801818688
45717	1986808509
45717	2032230820
45717	2051428027

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEI	6	2012-07-10
HQB	5	2012-04-23
MPA	4	2003-11-24
HQE	2	2012-06-21
LFL	2	2002-08-23
FRN	1	2009-10-30
MRH	1	2000-01-07
HQR	1	1996-01-05
HKP	1	1995-04-10

PMN#

SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
2009-10-30
SYNERGETICS, INC.
STRYKER INTRADISCAL RF GENERATOR
2007-05-23
SYNERGETICS, INC.
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
2003-11-24
SYNERGETICS, INC.
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
2002-08-23
SYNERGETICS, INC.
SONOTOME ULTRASONIC ASPIRATOR TIPS
2001-04-20
SYNERGETICS, INC.
SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01
1999-05-14
SYNERGETICS, INC.
VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010
1998-12-02
SYNERGETICS, INC.
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
1997-06-09
SYNERGETICS, INC.
OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
1994-02-23
SYNERGETICS, INC.
OPHTHALMIC PHARCO NEEDLE
1993-03-18
SYNERGETICS, INC.
OPHTHALMIC VISCOINJECTOR DRIVE
1992-09-30
SYNERGETICS, INC.