ClearanceBrief
Panels › Obstetrics/Gynecology › Product code HET · Class 2

Laparoscope, Gynecologic (And Accessories)

Regulation 884.1720

0510(k)s in 12 months (338 all time)
0recalls in 12 months (19 all time)
16recalls that name a 510(k)
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Top companies in HET

Decided510(k)Device and applicantCode
Oct 14, 1999K990372MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
Dr. Fritz GmbH
HET
Sep 23, 1999K992480MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
Medifix, Inc.
HET
Jul 23, 1999K990732LAP-WAVE 3000 (P07)
W.O.M. World of Medicine GmbH
HET
Apr 2, 1999K990004DCI ENDOSCOPE
KARL STORZ Endoscopy-America, Inc.
HET
Feb 18, 1999K982276BAHO AUTOCLAVABLE LAPAROSCOPE
Microptix Int'L, LLC
HET
Jan 19, 1999K982515POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh, DE
HET
Jan 14, 1999K982518AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh, DE
HET
Oct 9, 1998K982428CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
Innervision, Inc.
HET
Sep 10, 1998K982149SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
Smith & Nephew, Inc.
HET
Aug 19, 1998K981130KSEA ENDO TIP SYSTEM
KARL STORZ Endoscopy-America, Inc.
HET
Jul 21, 1998K970712LAPARO-TENSER
L & T S.N.C. DI E. Lucini & C., IT
HET
Jul 10, 1998K974763DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
Deroyal Industries, Inc.
HET
May 21, 1998K970968BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
Guenter Bissinger Medizintechnik GmbH, DE
HET
May 8, 1998K980694KSEA PLASTIC TROCARS
KARL STORZ Endoscopy-America, Inc.
HET
Apr 10, 1998K972647CO2 PNEUMO-DISSECTOR
Cook Urological, Inc.
HET
Apr 1, 1998K980166LIGHTSOURCE OR ILLUMINATOR
Cuda Products Co.
HET
Jan 22, 1998K972488KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES
Karl Storz Endoscopy
HET
Dec 19, 1997K962985KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES
KARL STORZ Endoscopy-America, Inc.
HET
Dec 12, 1997K973737MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M
Richard Wolf Medical Instruments Corp.
HET
Dec 2, 1997K973304MVM 3.3 MM MICROENDOSCOPE
KARL STORZ Endoscopy-America, Inc.
HET
Nov 7, 1997K971836VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
CooperSurgical, Inc.
HET
Oct 10, 1997K971896GALILEO HIGH RESOLUTION MICRO COUPLER
Netoptix Corp.
HET
Aug 6, 1997K971837VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
CooperSurgical, Inc.
HET
Aug 6, 1997K962777AMR MINI-LAPAROSCOPE
Applied Medical Resources
HET
Jul 22, 1997K971797LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
Louisville Laboratories, Inc.
HET
May 5, 1997K965045TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
Ethicon Endo-Surgery, Inc.
HET
Apr 21, 1997K971255IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
Imagyn Medical, Inc.
HET
Apr 4, 1997K963076LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
Louisville Laboratories, Inc.
HET
Mar 20, 1997K965121CANNULA
Origin Medsystems, Inc.
HET
Mar 18, 1997K970151INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
Smith & Nephew, Inc.
HET
Mar 6, 1997K965055IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
Imagyn Medical, Inc.
HET
Mar 4, 1997K970105RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
Richard Wolf Medical Instruments Corp.
HET
Feb 14, 1997K960640S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
HET
Feb 7, 1997K962246RIGID FIBER OPTIC LAPAROSCOPE
Health Care International Assoc.
HET
Jan 30, 1997K964436WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM
Western Surgical Instrument Co.
HET
Jan 29, 1997K964379KSEA PUNCTURE CANNULA
KARL STORZ Endoscopy-America, Inc.
HET
Jan 17, 1997K963872FEMRX MORCELLATOR SYSTEM
Gynecare Innovation Center
HET
Jan 10, 1997K964450SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
Pilling Weck Group
HET
Dec 20, 1996K963960KSEA UNIMAT PLUS
KARL STORZ Endoscopy-America, Inc.
HET
Dec 19, 1996K963949KSEA UNIMAT PLUS
KARL STORZ Endoscopy-America, Inc.
HET
Oct 28, 1996K960299PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
Richard Wolf Medical Instruments Corp.
HET
Oct 21, 1996K960810BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
Marlo Surgical Technology
HET
Sep 30, 1996K962090KARL STORZ MODEL 203210 O1 UNIMAT PLUS
KARL STORZ Endoscopy-America, Inc.
HET
Sep 24, 1996K963359INSUFFLATION NEEDLE
Applied Medical Resources
HET
Aug 29, 1996K961860A4907 LENS CLEANING SHEATH
Olympus America, Inc.
HET
Aug 9, 1996K961922RDP-2
Ranfac, Corp.
HET
Jul 24, 1996K960936RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
Origin Medsystems, Inc.
HET
Jul 1, 1996K960347SAFETY TROCER WITH SPRINGLOADED OBDURATOR
Spiess Design, Inc.
HET
Jun 7, 1996K954774SHIELDED TROCAR (OBTURATOR)
Gabris Surgical Corp.
HET
May 16, 1996K950335KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
KARL STORZ Endoscopy-America, Inc.
HET

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