Uromed Sling Kit
FDA 510(k) K980717 · Uromed Corp.
510(k) numberK980717
Submission
- Device name
- Uromed Sling Kit
- Applicant
- Uromed Corp.
Needham, MA, US - Received
- February 24, 1998
- Decision date
- May 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
|---|---|---|
| K010213 | Modification to Cavermap Surgical AidETN · Traditional | 04/20/2001SE |
| K010098 | Modification to Cavermap Surgical AidFGM · Special | 02/01/2001SE |
| K000507 | Cavermap Surgical AidETN · Traditional | 04/21/2000SE |
| K993436 | Cavermap Surgical AidFGM · Traditional | 02/11/2000SE |
| K982226 | Uromed Brachytheraphy IODINE-125 SourcesKXK · Traditional | 05/13/1999SE |
| K974600 | Uromed PatchMNG · Traditional | 03/31/1998SE |
| K974137 | Uromed Needle GrasperOCW · Traditional | 01/30/1998SE |
| K970971 | Uro Med Nerve StimulatorETN · Traditional | 10/27/1997SE |
| K971992 | Uromed Alternative Bladder Control Continence DEVICE(ABCPN-0026)FHA · Traditional | 08/01/1997SE |
Questions and answers
When was Uromed Sling Kit cleared by the FDA?
Uromed Sling Kit (K980717) received a 510(k) decision of Substantially Equivalent on May 22, 1998, 87 days after the submission was received.
What is the product code of K980717?
The FDA product code is KNA – Instrument, Manual, Specialized Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.