Mi-Mark Endocervical Sampling Set
FDA 510(k) K790923 · Simpson/Basye, Inc.
510(k) numberK790923
Submission
- Device name
- Mi-Mark Endocervical Sampling Set
- Applicant
- Simpson/Basye, Inc.
Mchenry, IL, US - Received
- May 15, 1979
- Decision date
- June 22, 1979
- 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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|---|---|---|---|
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| 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 |
|---|---|---|
| K926179 | Sedlacek HandleHGI · Traditional | 03/25/1994SE |
| K891352 | Marlow Anal SpeculumKOA · Traditional | 06/23/1989SE |
| K891351 | Newport Lateral Vaginal RetractorKOH · Traditional | 05/11/1989SE |
| K891350 | Newport Cervical ManipulatorHDC · Traditional | 03/29/1989SE |
| K891349 | Campion Cervical HookHDC · Traditional | 03/29/1989SE |
| K891347 | Reid Endocervical SpreaderHDC · Traditional | 03/29/1989SE |
| K891348 | Campion Laser ForcepsGEN · Traditional | 03/22/1989SE |
| K870276 | Heated Instrument BathLRJ · Traditional | 05/07/1987SE |
| K862717 | Hand Mirror (Endoscope)GCO · Traditional | 07/30/1986SE |
| K862629 | Surgical Laser Accessories (Sla) CaseFSM · Traditional | 07/17/1986SE |
Questions and answers
When was Mi-Mark Endocervical Sampling Set cleared by the FDA?
Mi-Mark Endocervical Sampling Set (K790923) received a 510(k) decision of Substantially Equivalent on June 22, 1979, 38 days after the submission was received.
What is the product code of K790923?
The FDA product code is KNA – Instrument, Manual, Specialized Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.