Product code KNA
- Device name
- Instrument, Manual, Specialized Obstetric-Gynecologic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130087 | PANPAC WORD/BARTHOLIN CATHETER | Panpac Medical Corporation | 2014-01-10 |
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | Cook Urological, Inc. | 2011-05-06 |
| K093904 | GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER | Glenveigh Surgical, LLC | 2010-04-14 |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | Cook Urological, Inc. | 2009-09-03 |
| K062438 | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | Cook Ob/Gyn | 2006-10-27 |
| K060289 | EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 | Frontline Medical | 2006-07-07 |
| K013597 | TAMPONADE UTERINE BALLOON CATHETER SET | Cook Ob/Gyn | 2002-04-17 |
| K014248 | DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER | Urogyn , Ltd. | 2002-03-21 |
| K001590 | DND 101 | Urogyn , Ltd. | 2000-08-02 |
| K990738 | DR. JAHANGER'S CUTTER | M.S. Jahanger, MD | 1999-10-29 |
| K990045 | BERACLAMP, MODEL BC-1 | Poamax LLC | 1999-05-24 |
| K982464 | SCC-23 SAFETY CLAMP AND CUTTER | Women First Healthcare, Inc. | 1998-08-11 |
| K980717 | UROMED SLING KIT | Uromed Corp. | 1998-05-22 |
| K980237 | GYNEX ENDOSPECULUM | Gynex Corp. | 1998-04-08 |
| K972013 | NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS | National Healthcare Mfg. Corp. | 1997-08-26 |
| K971277 | SAFE-T-CLAMP | Talon Medical, Ltd. | 1997-05-20 |
| K952527 | BALLOON UTERINE STENT | Cook Urological, Inc. | 1996-01-02 |
| K954619 | CORDGUARD II | Utah Medical Products, Inc. | 1995-12-21 |
| K951081 | OB/GYN PACKS | Sterile Concepts, Inc. | 1995-11-13 |
| K940907 | MADDEN SURGICAL THIMBLE | Kelley-Gilmer Medical Corp. | 1994-12-29 |
| K941641 | DISPOSABLE EMERGENCY OBSTETRICAL KIT | Gam Industries, Inc. | 1994-10-03 |
| K926532 | ENDO CERVICAL CURETTE | Thomasville Medical Assoc. | 1994-02-25 |
| K930031 | MICRO SURGERY SCISSORS | Thomasville Medical Assoc. | 1994-02-24 |
| K926529 | Z CLAMP SCISSORS | Thomasville Medical Assoc. | 1994-02-24 |
| K926537 | NEEDLE EXTENSIONS | Thomasville Medical Assoc. | 1994-02-24 |
| K926530 | MIYA HOOK | Thomasville Medical Assoc. | 1994-02-24 |
| K930727 | VARIOUS SCISSORS | Thomasville Medical Assoc. | 1994-02-24 |
| K930110 | MICRO SURGERY NEEDLE HOLDERS | Thomasville Medical Assoc. | 1994-02-24 |
| K930032 | RETRACTOR RODS | Thomasville Medical Assoc. | 1994-02-10 |
| K912075 | C-SECTION TRAY | Medical Device Inspection Co., Inc. | 1992-04-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10653160331100 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2019-11-04 |
| 10653160328636 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2019-08-23 |
| 10653160326045 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2019-04-13 |
| 10653160315858 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2018-03-29 |
| H671CRD2010 | Cordguard® | UTAH MEDICAL PRODUCTS, INC. | 2017-06-21 |
| 00827002554429 | Word | COOK INCORPORATED | 2016-09-24 |
| 00616784490229 | Obstetrical Kit | Dynarex Corporation | 2016-09-24 |
| 00616784490120 | Obstetrical Kit | Dynarex Corporation | 2016-09-24 |
| 00607915118105 | Alexis ® O C-Section Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915118112 | Alexis ® O C-Section Protector-Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915118129 | Alexis ® O C-Section Protector - Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00607915118136 | Alexis ® O C-Section Protector - Retractor | APPLIED MEDICAL RESOURCES CORPORATION | 2016-09-24 |
| 00888937013191 | HUI | Coopersurgical, Inc. | 2016-09-14 |
| 00653160010688 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-14 |
| 00888937013238 | HUMI | Coopersurgical, Inc. | 2016-09-14 |
| 07350025912318 | Cyst Puncture Needle without Stylet | Vitrolife Sweden AB | 2016-09-14 |
| 07350025912349 | Cyst Puncture Needle without Stylet | Vitrolife Sweden AB | 2016-09-14 |
| 20653160206238 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-14 |
| 10653160277873 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-14 |
| 00653160068269 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-13 |
| 00653160068276 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-13 |
| 00653160068283 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-13 |
| 00653160068252 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-13 |
| 10653160288817 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-09-13 |
| 00653160136098 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-08-31 |
| 00653160202533 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2016-08-31 |
| 04715309125038 | NA | PANPAC MEDICAL CORPORATION | 2016-08-15 |
| 00888937003567 | Pro-Ception | Coopersurgical, Inc. | 2016-08-09 |
| 60888937003576 | Pro-Ception | Coopersurgical, Inc. | 2016-08-09 |
| 04038653347957 | AESCULAP | Aesculap AG | 2016-05-30 |