FDA Product Code
FDA Product Code HIH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1690
510(k) Clearances — 175 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013870 | SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224 | Smith & Nephew, Inc. | 2002-01-17 | Traditional | PDF ↗ |
| K003802 | HYSTEROSCOPES | Global Endoscopy, Inc. | 2001-07-22 | Traditional | PDF ↗ |
| K001740 | KSEA MONOPOLAR VAPORIZATION ELECTRODES | KARL STORZ Endoscopy-America, Inc. | 2000-08-22 | Traditional | PDF ↗ |
| K000673 | HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 | Richard Wolf Medical Instruments Corp. | 2000-05-26 | Traditional | PDF ↗ |
| K994418 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | ETHICON, Inc. | 2000-01-24 | Special | PDF ↗ |
| K992901 | GYNECARE VERSAPOINT G-VAP ELECTRODE | Gynecare, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K993749 | GYRUS HYSTEROSCOPIC RESECTOSCOPE | Gyrus Medical , Ltd. | 1999-12-03 | Special | PDF ↗ |
| K991563 | CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C | Henke Sass Wolf of America, Inc. | 1999-10-13 | Traditional | PDF ↗ |
| K992027 | KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR | Karl Storz Endoscopy | 1999-09-09 | Traditional | PDF ↗ |
| K990910 | MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS | Mtp Medical Technical Promotion GmbH | 1999-06-03 | Traditional | PDF ↗ |
| K990411 | MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE | Karl Storz Endoscopy | 1999-05-11 | Traditional | PDF ↗ |
| K982738 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | Gynecare, Inc. | 1999-03-01 | Traditional | PDF ↗ |
| K983901 | KSEA HF-SNARE | KARL STORZ Endoscopy-America, Inc. | 1999-02-01 | Traditional | PDF ↗ |
| K982771 | GYRUS HYSTEROSCOPIC RESECTOSCOPE | Gyrus Medical , Ltd. | 1999-01-21 | Traditional | PDF ↗ |
| K983569 | KSEA MONOPOLAR VAPORIZATION ELECTRODES | KARL STORZ Endoscopy-America, Inc. | 1999-01-08 | Traditional | PDF ↗ |
| K982659 | MEDIVISION HYSTEROSCOPE | Medivision Scope Service Center, Inc. | 1998-10-07 | Traditional | PDF ↗ |
| K980302 | WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES | Richard Wolf Medical Instruments Corp. | 1998-07-20 | Traditional | PDF ↗ |
| K981828 | GALILEO DISPOSABLE HYSTEROSCOPES | Netoptix Corp. | 1998-07-07 | Traditional | PDF ↗ |
| K981800 | SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 | Equal Diagnostics, Inc. | 1998-07-06 | Traditional | PDF ↗ |
| K971374 | GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE | Wilson Greatbatch Technologies, Inc. | 1998-05-13 | Traditional | PDF ↗ |
| K974297 | GALILEO DISPOSABLE HYSTEROSCOPES | Netoptix Corp. | 1998-02-13 | Traditional | PDF ↗ |
| K971420 | MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212) | Richard Wolf Medical Instruments Corp. | 1997-10-22 | Traditional | PDF ↗ |
| K972426 | MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH | Imagyn Medical, Inc. | 1997-09-23 | Traditional | PDF ↗ |
| K972210 | RESECTOSCOPE SAFETY SHEATH | Conceptus, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K971305 | FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM | Gynecare Innovation Center | 1997-08-11 | Traditional | PDF ↗ |
| K962271 | ELECTROSURGICAL ELECRTRODES | Northgate Technologies, Inc. | 1997-08-08 | Traditional | PDF ↗ |
| K971518 | KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K971188 | SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS | Smith & Nephew, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K954488 | ROLLER ELECTRODE | Olympus America, Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K962256 | GALILEO HYSTEROSCOPES AND LAPAROSCOPES | Galileo Electro-Optics Corp. | 1996-12-06 | Traditional | PDF ↗ |
| K961605 | KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1996-11-13 | Traditional | PDF ↗ |
| K962482 | SCUBA SYSTEM | Gynecare, Inc. | 1996-11-01 | Traditional | PDF ↗ |
| K961688 | MICROSPAN HYSTEROSCOPE | Imagyn Medical, Inc. | 1996-10-15 | Traditional | PDF ↗ |
| K961506 | MICROSPAN HYSTEROSCOPE SHEATH | Imagyn Medical, Inc. | 1996-07-03 | Traditional | PDF ↗ |
| K954648 | FEMRX OPERASTAR SYSTEM | Gynecare Innovation Center | 1996-03-14 | Traditional | PDF ↗ |
| K954164 | HYSTEROSCOPE | Conceptus, Inc. | 1996-03-12 | Traditional | PDF ↗ |
| K952186 | HSW GMBH HYSTEROSCOPES & ACCESSORIES | Henke-Sass, Wolf GmbH | 1996-02-06 | Traditional | PDF ↗ |
| K955119 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | Symbiosis Corp. | 1996-01-18 | Traditional | PDF ↗ |
| K951946 | HYSTEROSYS FLEXIBLE HYSTEROCOPE | Ovamed Corp. | 1995-11-20 | Traditional | PDF ↗ |
| K940316 | HYSTERSCOPE | Stephen Chakoff, Inc. | 1995-11-16 | Traditional | PDF ↗ |
| K935716 | KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE | KARL STORZ Endoscopy-America, Inc. | 1995-11-16 | Traditional | PDF ↗ |
| K952032 | IMAGYN HYSTEROSCOPE SHEATHS | Imagyn Medical, Inc. | 1995-10-31 | Traditional | PDF ↗ |
| K952779 | KARL STORZ FLEXIBLE HYSTERSCOPE | KARL STORZ Endoscopy-America, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K945265 | OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES | Optus, Inc. | 1995-09-12 | Traditional | PDF ↗ |
| K953109 | HAND EXTRACTOR HECTOR | Karl Storz Endoscopy | 1995-08-25 | Traditional | PDF ↗ |
| K950255 | ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM | Argus Medical Co., Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K952033 | IMAGYN HYSTEROSCOPE | Imagyn Medical, Inc. | 1995-07-24 | Traditional | PDF ↗ |
| K933544 | FUJINON VIDEO LAPORASCOPE | Fujinon, Inc. | 1995-04-27 | Traditional | PDF ↗ |
| K950055 | A4722 OLYMPUS OPTICAL OBTURATOR | Olympus America, Inc. | 1995-02-21 | Traditional | PDF ↗ |
| K950036 | OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN | Olympus America, Inc. | 1995-02-09 | Traditional | PDF ↗ |
| K934286 | HYSTEROSCOPE | Bei Medical Systems Co., Inc. | 1994-07-19 | Traditional | PDF ↗ |
| K921942 | HYSTEROSCOPE (AND ACCESSORIES) | Optimed Technologies, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K922420 | CONTINUOUS FLOW HYSTERO-RESECTOSCOPE | Linvatec Corp. | 1994-06-14 | Traditional | PDF ↗ |
| K931764 | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES | Olympus Corp. | 1994-06-08 | Traditional | PDF ↗ |
| K922711 | FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE | Optimed Technologies, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K924631 | CABOT MEDICAL UTERINE RESECTOSCOPE | Cabot Medical Corp. | 1994-05-16 | Traditional | PDF ↗ |
| K931994 | RESECTOSCOPE SHEATH | Olympus Corp. | 1994-02-17 | Traditional | PDF ↗ |
| K914108 | RG27-SERIES RESECTOSCOPE AND ACCESSORIES | CooperSurgical, Inc. | 1992-03-19 | Traditional | PDF ↗ |
| K905392 | HT4-SERIES HYSTEROSCOPES AND ACCESSORIES | Frigitronics, Inc. | 1991-04-30 | Traditional | PDF ↗ |
| K903146 | HYSTEROSCOPY SHEATH SET | Cook, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K895857 | CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY | Richard Wolf Medical Instruments Corp. | 1990-06-22 | Traditional | PDF ↗ |
| K897003 | OLYMPUS HYSTERORESECTOSCOPE | Olympus Corp. | 1990-03-16 | Traditional | PDF ↗ |
| K896917 | HYSTEROSCOPE | Cabot Medical Corp. | 1990-03-05 | Traditional | PDF ↗ |
| K890328 | ADULT RESECTOSCOPE | Circon Video | 1990-02-06 | Traditional | PDF ↗ |
| K892390 | FLEXIBLE IMMERSIBLE HYSTEROSCOPE | Schott Fiber Optics, Inc. | 1990-02-02 | Traditional | PDF ↗ |
| K882270 | MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES | KARL STORZ Endoscopy-America, Inc. | 1989-10-20 | Traditional | PDF ↗ |
| K891451 | OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE | Olympus Corp. | 1989-10-02 | Traditional | PDF ↗ |
| K882761 | TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE) | Intramed Laboratories, Inc. | 1988-09-20 | Traditional | PDF ↗ |
| K880314 | HYSTEROSCOPE AUTONOM 4992 | Richard Wolf Medical Instruments Corp. | 1988-08-25 | Traditional | PDF ↗ |
| K881249 | BAGGISH, HYSTEROSCOPE | Bryan Corp. | 1988-07-28 | Traditional | PDF ↗ |
| K841825 | SCOPE LIGHT | Zinnanti Surgical Instruments, Inc. | 1984-06-15 | Traditional | PDF ↗ |
| K812202 | FIBER OPTIC LIGHT SOURCE | Reznik Instruments | 1981-09-29 | Traditional | PDF ↗ |
| K811270 | SCOPE MASTER | Synemed, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K810569 | CONTACT-MICRO COLPOHYSTEROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1981-07-16 | Traditional | PDF ↗ |
| K791330 | HYSTEROSER | A. B. Vacuum Extractor, Inc. | 1980-03-03 | Traditional | PDF ↗ |
Product code HIH · Class II · Obstetrics/Gynecology. Data: openFDA.