Phlebotomy Unit Sharps a Gator
FDA 510(k) K944114 · Devon Industries, Inc.
510(k) numberK944114
Submission
- Device name
- Phlebotomy Unit Sharps a Gator
- Applicant
- Devon Industries, Inc.
Chatsworth, CA, US - Received
- August 23, 1994
- Decision date
- December 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| K961993 | Birthday Kit (Obstetrical Delivery Kit)MLS · Traditional | 07/03/1996SE |
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| K945197 | The Sharps Collection and Disposal SystemMMK · Traditional | 12/02/1994SE |
| K943892 | Point of Use Sharps a GatorFMI · Traditional | 12/02/1994SE |
| K945485 | Abg Needle ProtectionCBT · Traditional | 11/29/1994SE |
| K932998 | Easy-OnGES · Traditional | 08/18/1993SE |
| K912824 | Devon Sponge Counter BagsLWH · Traditional | 08/26/1991SE |
| K894170 | Devon Disposable Head Positioner CoverKME · Traditional | 09/07/1989SE |
| K892660 | Hibernation KitCAZ · Traditional | 08/15/1989SE |
Questions and answers
When was Phlebotomy Unit Sharps a Gator cleared by the FDA?
Phlebotomy Unit Sharps a Gator (K944114) received a 510(k) decision of Substantially Equivalent on December 2, 1994, 101 days after the submission was received.
What is the product code of K944114?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.