FDA Product Code
FDA Product Code KNA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4530
510(k) Clearances — 58 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130087 | PANPAC WORD/BARTHOLIN CATHETER | Panpac Medical Corporation | 2014-01-10 | Traditional | PDF ↗ |
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | Cook Urological, Inc. | 2011-05-06 | Traditional | PDF ↗ |
| K093904 | GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER | Glenveigh Surgical, LLC | 2010-04-14 | Traditional | PDF ↗ |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | Cook Urological, Inc. | 2009-09-03 | Traditional | PDF ↗ |
| K062438 | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | Cook Ob/Gyn | 2006-10-27 | Traditional | PDF ↗ |
| K060289 | EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 | Frontline Medical | 2006-07-07 | Traditional | PDF ↗ |
| K013597 | TAMPONADE UTERINE BALLOON CATHETER SET | Cook Ob/Gyn | 2002-04-17 | Traditional | PDF ↗ |
| K014248 | DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER | Urogyn , Ltd. | 2002-03-21 | Traditional | PDF ↗ |
| K001590 | DND 101 | Urogyn , Ltd. | 2000-08-02 | Traditional | PDF ↗ |
| K990738 | DR. JAHANGER'S CUTTER | M.S. Jahanger, MD | 1999-10-29 | Traditional | PDF ↗ |
| K990045 | BERACLAMP, MODEL BC-1 | Poamax LLC | 1999-05-24 | Traditional | PDF ↗ |
| K982464 | SCC-23 SAFETY CLAMP AND CUTTER | Women First Healthcare, Inc. | 1998-08-11 | Traditional | PDF ↗ |
| K980717 | UROMED SLING KIT | Uromed Corp. | 1998-05-22 | Traditional | PDF ↗ |
| K980237 | GYNEX ENDOSPECULUM | Gynex Corp. | 1998-04-08 | Traditional | PDF ↗ |
| K972013 | NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS | National Healthcare Mfg. Corp. | 1997-08-26 | Traditional | PDF ↗ |
| K971277 | SAFE-T-CLAMP | Talon Medical, Ltd. | 1997-05-20 | Traditional | PDF ↗ |
| K952527 | BALLOON UTERINE STENT | Cook Urological, Inc. | 1996-01-02 | Traditional | PDF ↗ |
| K954619 | CORDGUARD II | Utah Medical Products, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K951081 | OB/GYN PACKS | Sterile Concepts, Inc. | 1995-11-13 | Traditional | PDF ↗ |
| K940907 | MADDEN SURGICAL THIMBLE | Kelley-Gilmer Medical Corp. | 1994-12-29 | Traditional | PDF ↗ |
| K941641 | DISPOSABLE EMERGENCY OBSTETRICAL KIT | Gam Industries, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K926532 | ENDO CERVICAL CURETTE | Thomasville Medical Assoc. | 1994-02-25 | Traditional | PDF ↗ |
| K930110 | MICRO SURGERY NEEDLE HOLDERS | Thomasville Medical Assoc. | 1994-02-24 | Traditional | PDF ↗ |
| K930727 | VARIOUS SCISSORS | Thomasville Medical Assoc. | 1994-02-24 | Traditional | PDF ↗ |
| K926530 | MIYA HOOK | Thomasville Medical Assoc. | 1994-02-24 | Traditional | PDF ↗ |
| K926529 | Z CLAMP SCISSORS | Thomasville Medical Assoc. | 1994-02-24 | Traditional | PDF ↗ |
| K926537 | NEEDLE EXTENSIONS | Thomasville Medical Assoc. | 1994-02-24 | Traditional | PDF ↗ |
| K930031 | MICRO SURGERY SCISSORS | Thomasville Medical Assoc. | 1994-02-24 | Traditional | PDF ↗ |
| K930032 | RETRACTOR RODS | Thomasville Medical Assoc. | 1994-02-10 | Traditional | PDF ↗ |
| K912075 | C-SECTION TRAY | Medical Device Inspection Co., Inc. | 1992-04-07 | Traditional | PDF ↗ |
| K891398 | RETRACTOR RODS | Zinnanti Surgical Instruments, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K891397 | GREENE-ARMYTAGE HEMOSTATIC FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K891399 | CORSON MYOMA GRASPING FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K891046 | SOPHER AND BIERER OVUM FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K891045 | MIYA HOOK | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K891048 | OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K891042 | MICRO SURGERY NEEDLE HOLDERS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K891040 | MICRO SURGERY SCISSORS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K891039 | MICRO SURGERY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K884291 | COOK HYSTEROCATH(TM) | Cook, Inc. | 1988-12-08 | Traditional | PDF ↗ |
| K880497 | WORD BARTHOLIN GLAND CATHETER CODE: 1005 | Hoosier Specialties, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K863439 | INTRAUTERINE HEMOSTASIS BALLOON STENT | Mentor Corp. | 1987-06-02 | Traditional | PDF ↗ |
| K871069 | MODIFIED HYSTEROSALPINGOGRAPY SET | Ackrad Laboratories | 1987-04-06 | Traditional | PDF ↗ |
| K864623 | OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT | Xanmed Corp. | 1987-01-14 | Traditional | PDF ↗ |
| K861385 | MILEX BARTHOLIN GLAND CATHETER | Milex Products, Inc. | 1986-06-16 | Traditional | PDF ↗ |
| K844823 | MICROINFERTILITY FORCEPS, TITANIUM | Precision Surgical Instrument, Inc. | 1985-01-16 | Traditional | PDF ↗ |
| K844821 | MICROINFERTILITY NEEDLE HOLDER, TITANIUM | Precision Surgical Instrument, Inc. | 1985-01-16 | Traditional | PDF ↗ |
| K844822 | MICROINFERTILITY SCISSORS, TITANIUM | Precision Surgical Instrument, Inc. | 1985-01-16 | Traditional | PDF ↗ |
| K842231 | ACKRAD HYSTEROSALPINGOGRAPHY SET | Ackrad Laboratories | 1984-09-19 | Traditional | PDF ↗ |
| K810483 | FALLOPIAN TUBE FORCEPS | American V. Mueller | 1981-03-11 | Traditional | PDF ↗ |
| K810484 | OVARY FORCEPS | American V. Mueller | 1981-03-11 | Traditional | PDF ↗ |
| K792631 | STERILIZATION PROCESS/DBL. GRIP CORD CLP | Procter & Gamble Mfg. Co. | 1980-01-28 | Traditional | PDF ↗ |
| K790853 | EASY-SPEC | C. Intl. | 1979-07-30 | Traditional | PDF ↗ |
| K790852 | VAGI-SPEC | C. Intl. | 1979-07-30 | Traditional | PDF ↗ |
| K790923 | MI-MARK ENDOCERVICAL SAMPLING SET | Simpson/Basye, Inc. | 1979-06-22 | Traditional | PDF ↗ |
| K780587 | GYNESURG | Polamedco, Inc. | 1978-05-25 | Traditional | PDF ↗ |
| K770641 | MINI-CONER TM | Medical Testing System, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K770727 | MANIPULATOR & INJECTOR, UTERINE | National Catheter Co. Div. Mallinckrodt | 1977-04-26 | Traditional | PDF ↗ |
Product code KNA · Class II · Obstetrics/Gynecology. Data: openFDA.