Obstetrical/Gynecological Custom Surgical Kit
FDA 510(k) K864623 · Xanmed Corp.
510(k) numberK864623
Submission
- Device name
- Obstetrical/Gynecological Custom Surgical Kit
- Applicant
- Xanmed Corp.
Central Islip, NY, US - Received
- November 25, 1986
- Decision date
- January 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNA – Instrument, Manual, Specialized Obstetric-Gynecologic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K130087 | Panpac Word/Bartholin CatheterKNA · Traditional | Panpac Medical Corporation | 01/10/2014SE |
| K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)KNA · Traditional | Cook Urological, Inc. | 05/06/2011SE |
| K093904 | Glenveigh Vaginal Tamponade Balloon CatheterKNA · Traditional | Glenveigh Surgical, LLC | 04/14/2010SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | Cook Urological, Inc. | 09/03/2009SE |
| K062438 | Bakri Postpartum Balloon, Model J-SOS-100500KNA · Traditional | Cook Ob/Gyn | 10/27/2006SE |
| K060289 | Epistat, V-Stat, Models EPISTAT-001-01, V-STAT-001-01KNA · Traditional | Frontline Medical | 07/07/2006SE |
| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | Cook Ob/Gyn | 04/17/2002SE |
| K014248 | DND 202 Manual Urological Digital Needle DriverKNA · Traditional | Urogyn , Ltd. | 03/21/2002SE |
| K001590 | DND 101KNA · Traditional | Urogyn , Ltd. | 08/02/2000SE |
| K990738 | Dr. Jahanger's CutterKNA · Traditional | M.S. Jahanger, MD | 10/29/1999SE |
More from M.S. Jahanger, MD
| 510(k) | Device | Decision |
|---|---|---|
| K844595 | Orthopedic Custom Surgical KitLXH · Traditional | 08/21/1985SE |
| K844596 | Emergency Room & Minor Office Procedure Custom Kit · Traditional | 08/01/1985SESD |
| K844593 | Cardiovascular Custom Surgical KitDYB · Traditional | 06/21/1985SE |
| K844594 | Neuro Custom Surgical KitHBA · Traditional | 06/13/1985SE |
| K851906 | Surgical Eye PackHMP · Traditional | 05/21/1985SE |
| K844597 | Miscellaneous General Surgical Custom Kit · Traditional | 04/08/1985SE |
| K843642 | Subclavian Lead Introducer SysDYB · Traditional | 10/23/1984SE |
| K843641 | Catheter Introducer SystemDYB · Traditional | 10/23/1984SE |
Questions and answers
When was Obstetrical/Gynecological Custom Surgical Kit cleared by the FDA?
Obstetrical/Gynecological Custom Surgical Kit (K864623) received a 510(k) decision of Substantially Equivalent on January 14, 1987, 50 days after the submission was received.
What is the product code of K864623?
The FDA product code is KNA – Instrument, Manual, Specialized Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.