Deroyal Surgical, Umbilicup
FDA 510(k) K020753 · Deroyal
510(k) numberK020753
Submission
- Device name
- Deroyal Surgical, Umbilicup
- Applicant
- Deroyal
Powell, TN, US - Received
- March 7, 2002
- Decision date
- June 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KSR – Container, Empty, For Collection & Processing Of Blood & Blood Components
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9100
- Specialty
- Hematology
Other 510(k)s with product code KSR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032827 | Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501KSR · Traditional | Tyco Healthcare | 12/08/2003SE |
| K810897 | Alpha Plastic Plasma BottleKSR · Traditional | Alpha Therapeutic Corp. | 09/23/1981SE |
| K810500 | Blood Freezing BagKSR · Traditional | Delmed, Inc. | 09/23/1981SE |
| K811523 | Plasma FlexKSR · Traditional | Terumo America, Inc. | 09/09/1981SE |
| K811449 | Haemonetics 1000ML Component BagKSR · Traditional | Haemonetics Corp. | 07/01/1981SE |
| K810711 | Haemonetics 600 Ml. Component BagKSR · Traditional | Haemonetics Corp. | 05/08/1981SE |
| K810313 | Haemonetics 1400 ML Therapeutic BagKSR · Traditional | Haemonetics Corp. | 03/31/1981SE |
| K801219 | PlasmapoolerKSR · Traditional | North American Biologicals, Inc. | 10/31/1980SE |
| K801082 | Gambro Hemofreeze-BagKSR · Traditional | Gambro, Inc. | 10/31/1980SE |
| K792395 | Pharmaflex Cryogenic BagKSR · Traditional | Pharmachem Corp. | 02/26/1980SE |
More from Pharmachem Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K041416 | Exac-Temp Foley Catheter and Clini-Temp Foley CatheterEYC · Abbreviated | 07/02/2004SE |
| K033057 | Deroyal Surgical Gowns, Sterile, Non-SterileFYA · Traditional | 11/20/2003SE |
| K031408 | Deroyal Poly-Reinforced Surgical Gowns (Sterile, Non-Sterile)FYA · Traditional | 10/15/2003SE |
| K030908 | Deroyal Surgical Drapes Backtable CoverKKX · Traditional | 08/11/2003SE |
Questions and answers
When was Deroyal Surgical, Umbilicup cleared by the FDA?
Deroyal Surgical, Umbilicup (K020753) received a 510(k) decision of Substantially Equivalent on June 13, 2002, 98 days after the submission was received.
What is the product code of K020753?
The FDA product code is KSR – Container, Empty, For Collection & Processing Of Blood & Blood Components, a Class II (moderate risk) device regulated under 21 CFR 864.9100.