C-Section Tray
FDA 510(k) K940518 · Cush Medical Products
510(k) numberK940518
Submission
- Device name
- C-Section Tray
- Applicant
- Cush Medical Products
Piney Flats, TN, US - Received
- February 4, 1994
- Decision date
- August 18, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MLS – Labor And Delivery Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Other 510(k)s with product code MLS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961993 | Birthday Kit (Obstetrical Delivery Kit)MLS · Traditional | Devon Industries, Inc. | 07/03/1996SE |
| K960243 | CPR C-Section Delivery PackMLS · Traditional | Custom Pack Reliability | 05/23/1996SE |
| K932216 | C-Section, Labor & Delivery Trays (Packs)MLS · Traditional | Associated Medical Products Co. | 04/19/1994SESK |
| K936120 | Labor and Delivery TrayMLS · Traditional | Cush Medical Products | 03/30/1994SEKD |
| K931722 | Carapace Labor and Delivery SetsMLS · Traditional | Carapace, Inc. | 03/23/1994SEKD |
More from Carapace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943424 | Cush Island DressingMGP · Traditional | 10/03/1994SN |
| K941349 | Dental TrayEIA · Traditional | 07/26/1994SN |
| K941645 | Biopsy TrayFRG · Traditional | 07/14/1994SEKD |
| K940239 | Eye TrayLRP · Traditional | 06/28/1994SEKD |
| K935684 | IV Start KitLRS · Traditional | 06/10/1994SEKD |
| K941455 | Sterile Gauze Product LineEFQ · Traditional | 05/20/1994SESK |
| K941522 | Sterile X-Ray Detectable Gauze SpongesGDY · Traditional | 05/12/1994SE |
| K941344 | Lap Sponge Product LineGDY · Traditional | 05/12/1994SE |
| K935697 | Circumcision TrayHFX · Traditional | 05/02/1994SEKD |
| K936120 | Labor and Delivery TrayMLS · Traditional | 03/30/1994SEKD |
Questions and answers
When was C-Section Tray cleared by the FDA?
C-Section Tray (K940518) received a 510(k) decision of Unknown on August 18, 1994, 195 days after the submission was received.
What is the product code of K940518?
The FDA product code is MLS – Labor And Delivery Kit, a Class II (moderate risk) device regulated under 21 CFR 884.4530.