Atlas FDA

KNA

58 FDA 510(k) clearances · Product code

81 daysmedian time to decision
409 days90th percentile
58clearances measured

FDA profile

Official device name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2011: 13 · 2012: 8 · 2015: 8 · 2016: 22 · 2017: 37 · 2018: 63
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PANPAC WORD/BARTHOLIN CATHETER (K130087)Panpac Medical Corporation2014-01-10
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (K102141)Cook Urological, Inc.2011-05-06
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER (K093904)Glenveigh Surgical, LLC2010-04-14
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (K082939)Cook Urological, Inc.2009-09-03
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (K062438)Cook Ob/Gyn2006-10-27
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 (K060289)Frontline Medical2006-07-07
TAMPONADE UTERINE BALLOON CATHETER SET (K013597)Cook Ob/Gyn2002-04-17
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER (K014248)Urogyn , Ltd.2002-03-21
DND 101 (K001590)Urogyn , Ltd.2000-08-02
DR. JAHANGER'S CUTTER (K990738)M.S. Jahanger, MD1999-10-29
BERACLAMP, MODEL BC-1 (K990045)Poamax LLC1999-05-24
SCC-23 SAFETY CLAMP AND CUTTER (K982464)Women First Healthcare, Inc.1998-08-11
UROMED SLING KIT (K980717)Uromed Corp.1998-05-22
GYNEX ENDOSPECULUM (K980237)Gynex Corp.1998-04-08
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS (K972013)National Healthcare Mfg. Corp.1997-08-26
SAFE-T-CLAMP (K971277)Talon Medical, Ltd.1997-05-20
BALLOON UTERINE STENT (K952527)Cook Urological, Inc.1996-01-02
CORDGUARD II (K954619)Utah Medical Products, Inc.1995-12-21
OB/GYN PACKS (K951081)Sterile Concepts, Inc.1995-11-13
MADDEN SURGICAL THIMBLE (K940907)Kelley-Gilmer Medical Corp.1994-12-29
DISPOSABLE EMERGENCY OBSTETRICAL KIT (K941641)Gam Industries, Inc.1994-10-03
ENDO CERVICAL CURETTE (K926532)Thomasville Medical Assoc.1994-02-25
NEEDLE EXTENSIONS (K926537)Thomasville Medical Assoc.1994-02-24
MIYA HOOK (K926530)Thomasville Medical Assoc.1994-02-24
MICRO SURGERY NEEDLE HOLDERS (K930110)Thomasville Medical Assoc.1994-02-24
MICRO SURGERY SCISSORS (K930031)Thomasville Medical Assoc.1994-02-24
VARIOUS SCISSORS (K930727)Thomasville Medical Assoc.1994-02-24
Z CLAMP SCISSORS (K926529)Thomasville Medical Assoc.1994-02-24
RETRACTOR RODS (K930032)Thomasville Medical Assoc.1994-02-10
C-SECTION TRAY (K912075)Medical Device Inspection Co., Inc.1992-04-07
RETRACTOR RODS (K891398)Zinnanti Surgical Instruments, Inc.1989-05-11
GREENE-ARMYTAGE HEMOSTATIC FORCEPS (K891397)Zinnanti Surgical Instruments, Inc.1989-03-29
CORSON MYOMA GRASPING FORCEPS (K891399)Zinnanti Surgical Instruments, Inc.1989-03-29
OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC (K891048)Zinnanti Surgical Instruments, Inc.1989-03-22
MIYA HOOK (K891045)Zinnanti Surgical Instruments, Inc.1989-03-22
SOPHER AND BIERER OVUM FORCEPS (K891046)Zinnanti Surgical Instruments, Inc.1989-03-22
MICRO SURGERY SCISSORS (K891040)Zinnanti Surgical Instruments, Inc.1989-03-17
MICRO SURGERY FORCEPS (K891039)Zinnanti Surgical Instruments, Inc.1989-03-17
MICRO SURGERY NEEDLE HOLDERS (K891042)Zinnanti Surgical Instruments, Inc.1989-03-17
COOK HYSTEROCATH(TM) (K884291)Cook, Inc.1988-12-08
WORD BARTHOLIN GLAND CATHETER CODE: 1005 (K880497)Hoosier Specialties, Inc.1988-03-24
INTRAUTERINE HEMOSTASIS BALLOON STENT (K863439)Mentor Corp.1987-06-02
MODIFIED HYSTEROSALPINGOGRAPY SET (K871069)Ackrad Laboratories1987-04-06
OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT (K864623)Xanmed Corp.1987-01-14
MILEX BARTHOLIN GLAND CATHETER (K861385)Milex Products, Inc.1986-06-16
MICROINFERTILITY NEEDLE HOLDER, TITANIUM (K844821)Precision Surgical Instrument, Inc.1985-01-16
MICROINFERTILITY SCISSORS, TITANIUM (K844822)Precision Surgical Instrument, Inc.1985-01-16
MICROINFERTILITY FORCEPS, TITANIUM (K844823)Precision Surgical Instrument, Inc.1985-01-16
ACKRAD HYSTEROSALPINGOGRAPHY SET (K842231)Ackrad Laboratories1984-09-19
OVARY FORCEPS (K810484)American V. Mueller1981-03-11
FALLOPIAN TUBE FORCEPS (K810483)American V. Mueller1981-03-11
STERILIZATION PROCESS/DBL. GRIP CORD CLP (K792631)Procter & Gamble Mfg. Co.1980-01-28
VAGI-SPEC (K790852)C. Intl.1979-07-30
EASY-SPEC (K790853)C. Intl.1979-07-30
MI-MARK ENDOCERVICAL SAMPLING SET (K790923)Simpson/Basye, Inc.1979-06-22
GYNESURG (K780587)Polamedco, Inc.1978-05-25
MINI-CONER TM (K770641)Medical Testing System, Inc.1977-06-24
MANIPULATOR & INJECTOR, UTERINE (K770727)National Catheter Co. Div. Mallinckrodt1977-04-26

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Every clearance here is in the API, with alerts when new ones post.