COOPERSURGICAL, INC.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1216677	1216677	COOPERSURGICAL, INC.	1	Y	2026-01-01	95 CORPORATE DRIVE Trumbull CT US 06611

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
43589	1708090480	P000032	HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM	MNB	2001-04-20
43589	1067280121	K993881	GENX CULTURE DISH	MQK	2000-02-14
43589	2045532364	K993699	THE STRIPPER	MQH	2000-05-16
43589	1262978069	K992736	WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM	HIB	1999-09-29
43589	1530934452	K991669	PMS 750 FINGERSWITCH	GEI	1999-08-12
43589	1388474690	K991470	MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060)	MQL	2000-03-07
43589	1422795648	K991441	CADENCE DOPPLER ULTRASOUND SYSTEM	KNG	1999-12-28
43589	1001710800	K991396	WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L	MQL	2000-02-15
43589	2064842902	K991395	QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM	MQL	2000-02-15
43589	1202172124	K991393	HYALURONIDASE, 80 U/ML	MQL	2000-02-02
43589	1662509067	K991392	HUMAN SERUM ALBUMIN	MQL	2000-02-07
43589	1360236014	K991391	PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF	MQL	2000-01-10
43589	1967326455	K991390	1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI	MQL	2000-01-18
43589	1988598766	K991381	PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA	MQL	1999-09-24
43589	1815285869	K991380	OIL FOR TISSUE CULTURE	MQL	2000-04-19
43589	1624548176	K991379	QUINN'S SPERM WASHING MEDIUM	MQL	2000-02-02
43589	1692239899	K991378	PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED	MQL	1999-09-24
43589	1827598012	K991335	MEDI-CULT FREEZING & THAWING PACKS	MQL	2000-02-28
43589	1841682120	K991333	MEDI-CULT SPERM FREEZE MEDIUM	MQL	2000-02-28
43589	1874446235	K991332	MEDI-CULT SPERM PREPARATION - MEDIUM;	MQL	2000-05-04
43589	1305370729	K991330	MEDI-CULT LIQUID PARAFFIN	MQL	2000-02-25
43589	1555989647	K991329	MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE	MQL	2000-02-25
43589	1647862053	K991327	MEDI-CULT FLUSHING MEDIUM	MQL	2000-05-04
43589	1492135396	K991279	MEDI-CULT UNIVERSAL IVF-MEDIUM	MQL	2000-07-20
43589	1735185975	K991261	ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET	MQH	1999-08-05
43589	1438189259	K991229	K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L	MQG	1999-06-29
43589	1792404148	K991216	HOFFMAN IVF-1	MQG	1999-08-05
43589	1449484786	K991173	<GENX> FERTILIZATION MEDIA-HTF	MQL	1999-07-19
43589	2024309162	K990847	INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M	MQH	1999-07-14
43589	1018094535	K990350	WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316	MQF	1999-07-26
43589	1397807667	K990349	WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST	MQF	1999-07-26
43589	1530112690	K990348	WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N	MQF	1999-07-26
43589	1717870676	K984600	METRA PS PROCEDURE KIT	GCJ	1999-06-03
43589	1880855643	K984306	`THE INSEMINATOR' (PROPOSED)	MFD	1999-03-01
43589	1654515154	K980212	MITYVAC	HDB	1998-07-09
43589	1126270921	K980123	CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET	GCJ	1998-03-09
43589	1172057649	K974819	SELECTCELLS(TM) MINI	HHK	1998-03-23
43589	1200756200	K974168	COOPERSURGICAL INFRARED COAGULATOR	KNS	1998-01-23
43589	1678259883	K972630	COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM	HEX	1998-02-02
43589	1799672933	K970788	PNEUMO-MATIC INSUFFLATION NEEDLE	FHO	1997-03-27
43589	1203731488	K970492	INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER	LKF	1997-04-09
43589	1589545747	K964848	WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM	MFD	1997-01-16
43589	1388624561	K964001	SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM	ITX	1998-04-17
43589	1338785363	K963653	WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM	HGI	1997-06-11
43589	1215224596	K963348	WALLACH INTEGRATION UNIT	HGI	1997-03-19
43589	1073261083	K961752	H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)	LKF	1996-08-08
43589	1230856689	K961116	FIRST BEAT/CARDIO BEAT/CALC	IYO	1996-08-08
43589	1297197321	K960810	BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM	HET	1996-10-21
43589	1368537502	K954311	KOH COLPOTOMIZER SYSTEM	HEW	1996-11-19
43589	2045981950	K954102	SELECTMUCUS	HFC	1995-11-21
43589	1511334198	K954099	SELECT IUI	MFD	1995-11-22
43589	1148918453	K954097	SELECTCELLS STANDARD	HHK	1995-11-21
43589	2046258843	K953734	LUMAX(MODIFICATION)	FEN	1996-01-18
43589	1378892464	K953541	INSTANT COLDGEL	IMD	1995-10-05
43589	1979427943	K953034	H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)	LKF	1995-08-29
43589	1473370982	K952652	MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER	HHK	1995-09-15
43589	1598777231	K952542	ACKRAD ESOPHAGEAL BALLOON CATHETER SET	BZC	1996-04-23
43589	1548863341	K951898	VERSA-VU	HIB	1995-12-11
43589	1188476495	K943938	MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE	HDB	1995-05-03
43589	1300663574	K943201	CLEAN AIR	GEX	1995-02-28
43589	2064786668	K941458	UTERINE MANIPULATOR/INJECTOR WITH SPRING	LKF	1995-01-25
43589	1814530284	K941457	UTERINE INJECTOR WITH SPRING	LKF	1995-01-24
43589	1301176612	K940094	COLPOSCOPES AND ACCESSORIES	HEX	1995-04-25
43589	1742303186	K936011	INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM	HET	1994-09-21
43589	1696027771	K935634	WALLACH LEEP PROCEDURE KIT	HGI	1994-07-20
43589	1815270504	K935010	WALLACH ULTRA FREEZE	GEH	1994-02-09
43589	1521614411	K934631	TRANSWARMER	IMD	1994-02-03
43589	1273985328	K934011	MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE	HDB	1994-05-04
43589	1534633902	K932634	NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES	HET	1994-02-25
43589	1270734852	K932115	ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI	LKF	1994-06-24
43589	1521908086	K926104	POLYP NET	GCJ	1993-04-05
43589	1198748799	K921791	WALLACH LEAP 100 ELECTRO SURGERY SYSTEM	HGI	1995-05-04
43589	1908719337	K920803	HSG TRAY	HIB	1992-10-19
43589	1551259419	K914869	MARLOW LAPAROSCOPIC SCISSORS	GCJ	1992-01-15
43589	1384871689	K914241	PIONEER PRO-PUMP DUAL CONTROL	HHK	1992-03-04
43589	1627228848	K914220	PIONEER PRO-PUMP	HHK	1992-03-04
43589	1726527584	K913324	MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT	HDB	1992-06-22
43589	1129842477	K912715	INSTANT WARM GEL PACK	IMD	1991-10-02
43589	1280043997	K911780	INFANT NASAL CANNULAE ASSEMBLY, MODIFIED	BZD	1991-06-24
43589	1253580457	K911462	SURGICAL TROCAR	DRC	1991-04-22
43589	1103786245	K910907	PUMP VAC PLUS	HET	1991-05-13
43589	1814922348	K910377	COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM	GCX	1991-04-19
43589	1122128963	K910317	UNI-SEM(TM)	MFD	1991-05-01
43589	1312236616	K910253	LEEP REDIKIT	HEE	1991-04-18
43589	1312236616	K910253	LEEP REDIKIT	HEE	1991-04-18
43589	1867326339	K910252	POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE	HEE	1991-03-04
43589	1667622307	K905747	LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR	HGI	1991-09-17
43589	1367062528	K905393	HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR	FWF	1991-01-16
43589	1751539396	K905392	HT4-SERIES HYSTEROSCOPES AND ACCESSORIES	HIH	1991-04-30
43589	1078722247	K904774	INGLAT-O-BALL	HHW	1990-12-07
43589	1291574772	K904473	KRONNER MANIPUJECTOR	HES	1990-12-14
43589	1015578203	K904026	INFLAT-O-BALL	HHW	1990-10-10
43589	1631655859	K903560	CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS	HET	1990-11-06
43589	1603164837	K902693	WALLACH FLEXIBLE ENDOMETRIAL SAMPLER	HFF	1991-01-31
43589	1359071072	K900308	SPERM SELECT SYSTEM	HDR	1990-04-13
43589	2037632639	K897070	ENDOBRUSH(TM) DEVICE; OMNIBRUSH	HFE	1990-09-10
43589	1248671172	K896065	WALLACH CC/BRUSH	HHT	1990-01-04
43589	1184169753	K895675	PAP SMEAR TRAY	HHT	1989-12-11
43589	1653059452	K895659	HUI MINI-FLEX	HIG	1989-12-19
43589	2005984996	K895404	UNDER BUTTOCKS DRAPE	KKX	1989-10-06
43589	1994373153	K895403	ASPIRETTE ENDOCERVICAL ASPIRATOR	HFC	1989-11-29
43589	1619015641	K891045	MIYA HOOK	KNA	1989-03-22
43589	1278173828	K890848	CERVEX-BRUSH	HHT	1989-05-11
43589	1993997954	K890307	MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE	HDB	1989-03-31
43589	1563990553	K882404	KEVOR-CURETTE	PCF	1988-07-08
43589	1340416041	K872277	TRAKEFIT TRACHEOSTOMY TUBE HOLDER	CBH	1987-07-21
43589	1401518069	K871683	COLPOSTAR V-6	HEX	1987-08-05
43589	1519500702	K871682	WALLACH CONVERTIBLE COLPOSCOPE	HEX	1987-06-24
43589	1062962849	K861389	PAP SMEAR KIT	HHT	1986-05-02
43589	1464163356	K861017	GALENICA'S DISPOSABLE ANOSCOPES	FER	1986-06-13
43589	1936361033	K854895	BASKET FORCEP	KDC	1986-05-02
43589	1457006661	K854767	LM 1000	GEH	1986-01-24
43589	1967728991	K854415	ENDOMETRIAL PIPELLE	HHK	1986-03-13
43589	1503438595	K853389	WALLACH ZOOM COLPOSCOPE	HEX	1985-11-19
43589	1515172957	K850309	COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK	JAY	1985-02-14
43589	1622206960	K841909	VAGINAL SPECULUM - DISPOSABLE	HIB	1984-07-31
43589	1622206960	K841909	VAGINAL SPECULUM - DISPOSABLE	HIB	1984-07-31
43589	1358177206	K840536	CRYO SURG 5900	GEH	1984-04-23
43589	1926812354	K832986	PAP SMEAR BRUSH	HHT	1984-02-10
43589	1998911481	K813402	WA-2000 TEMPERATURE INDICATOR	FLL	1982-01-12

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
MQL	52	2020-07-17
LKF	13	2022-10-28
MQH	8	2017-01-23
MQF	8	2003-12-19
HHK	8	2000-06-15
HEX	6	2014-10-23
HIB	6	2010-02-16
HGI	6	2006-10-20
GCJ	6	2002-02-15
HDB	6	2001-07-30
GEH	6	1994-02-09
HIH	5	2019-05-15
MQK	5	2018-03-08
MQG	5	2014-05-07
MFD	5	2001-10-11
HET	5	1996-10-21
HHT	5	1990-01-04
HEW	4	2020-05-21
MQE	4	2019-06-12
HEE	4	2002-07-12
ITX	3	2018-07-17
HHW	3	2002-02-11
IMD	3	1995-10-05
OQY	2	2022-10-28
JAF	2	2009-12-24
GAD	2	2005-04-26
KNG	2	2003-01-03
GEI	2	2002-06-03
HFC	2	1995-11-21
KNA	2	1989-03-22
KOA	2	1981-05-08
PUB	1	2020-01-14
PWB	1	2017-07-27
MPO	1	2016-03-18
PFJ	1	2013-09-27
GDW	1	2012-03-16
DPW	1	2011-03-16
DXN	1	2011-02-15
MAA	1	2009-03-31
HDW	1	2008-01-23

NDC

TRIMO SAN

CooperSurgical, Inc.

Oxyquinoline Sulfate and Sodium Lauryl Sulfate

PMA

Mara Water Vapor Ablation System

2023-01-19

CooperSurgical, Inc.95 Corporate Drivetrumbull, CT 06611 PMA NumberP160047 Supplement NumberS028 Date Received12/21/2022 Decision Date01/19/2023 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Proces...

Mara Water Vapor Ablation System

2022-12-12

CooperSurgical, Inc.95 Corporate Drivetrumbull, CT 06611 PMA NumberP160047 Supplement NumberS027 Date Received11/14/2022 Decision Date12/12/2022 Product Code MNB Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Proces...