C-Section Tray
FDA 510(k) K912075 · Medical Device Inspection Co., Inc.
510(k) numberK912075
Submission
- Device name
- C-Section Tray
- Applicant
- Medical Device Inspection Co., Inc.
Great Neck, NY, US - Received
- May 10, 1991
- Decision date
- April 7, 1992
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K945826 | J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software…HCC · Traditional | 08/04/1995SE |
| K932072 | Jarit Surgical InstrumentsHET · Traditional | 01/11/1994SE |
| K931594 | Thera-Turn CM-1000 Mattress Overlay SystemIOQ · Traditional | 12/21/1993SE |
| K933581 | Powermatic Treatment TableINQ · Traditional | 11/05/1993SE |
| K933580 | Power Work TableINQ · Traditional | 11/05/1993SE |
| K933578 | Powermatic Mat PlatformINQ · Traditional | 11/05/1993SE |
| K933577 | Powermatic Examination TableINQ · Traditional | 09/30/1993SE |
| K922045 | Shower ChairsINM · Traditional | 05/26/1992SE |
| K914174 | Sterile Disposable Wet Skin Scrub TrayLRO · Traditional | 02/24/1992SEKD |
| K920403 | Xenon Arc Endoscope Light SourceGCJ · Traditional | 02/21/1992SE |
Questions and answers
When was C-Section Tray cleared by the FDA?
C-Section Tray (K912075) received a 510(k) decision of Unknown on April 7, 1992, 333 days after the submission was received.
What is the product code of K912075?
The FDA product code is KNA – Instrument, Manual, Specialized Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.