KNA — Instrument, Manual, Specialized Obstetric-Gynecologic Class II
FDA Device Classification
Classification Details
- Product Code
- KNA
- Device Class
- Class II
- Regulation Number
- 884.4530
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K130087 | panpac medical corporation | PANPAC WORD/BARTHOLIN CATHETER | January 10, 2014 |
| K102141 | cook urological | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | May 6, 2011 |
| K093904 | glenveigh surgical | GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER | April 14, 2010 |
| K082939 | cook urological | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | September 3, 2009 |
| K062438 | cook ob/gyn | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | October 27, 2006 |
| K060289 | frontline medical | EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 | July 7, 2006 |
| K013597 | cook ob/gyn | TAMPONADE UTERINE BALLOON CATHETER SET | April 17, 2002 |
| K014248 | urogyn | DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER | March 21, 2002 |
| K001590 | urogyn | DND 101 | August 2, 2000 |
| K990738 | m.s. jahanger, md | DR. JAHANGER'S CUTTER | October 29, 1999 |
| K990045 | poamax | BERACLAMP, MODEL BC-1 | May 24, 1999 |
| K982464 | women first healthcare | SCC-23 SAFETY CLAMP AND CUTTER | August 11, 1998 |
| K980717 | uromed | UROMED SLING KIT | May 22, 1998 |
| K980237 | gynex | GYNEX ENDOSPECULUM | April 8, 1998 |
| K972013 | national healthcare mfg | NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS | August 26, 1997 |
| K971277 | talon medical | SAFE-T-CLAMP | May 20, 1997 |
| K952527 | cook urological | BALLOON UTERINE STENT | January 2, 1996 |
| K954619 | utah medical products | CORDGUARD II | December 21, 1995 |
| K951081 | sterile concepts | OB/GYN PACKS | November 13, 1995 |
| K940907 | kelley-gilmer medical | MADDEN SURGICAL THIMBLE | December 29, 1994 |