Instrument Tip Protection Covers
FDA 510(k) K834127 · Devon Industries, Inc.
510(k) numberK834127
Submission
- Device name
- Instrument Tip Protection Covers
- Applicant
- Devon Industries, Inc.
Mchenry, IL, US - Received
- November 29, 1983
- Decision date
- February 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LXZ – Guard, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LXZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955463 | Grip-A-BootsLXZ · Traditional | Sil-Med Corp. | 01/23/1996SE |
More from Sil-Med Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K961993 | Birthday Kit (Obstetrical Delivery Kit)MLS · Traditional | 07/03/1996SE |
| K954015 | Abg Point Lok Needle Protection DeviceCBT · Traditional | 11/20/1995SE |
| K946289 | Devons Point Lok Needle Protection DeviceFMI · Traditional | 07/10/1995SE |
| K945197 | The Sharps Collection and Disposal SystemMMK · Traditional | 12/02/1994SE |
| K944114 | Phlebotomy Unit Sharps a GatorFMI · 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 |
Questions and answers
When was Instrument Tip Protection Covers cleared by the FDA?
Instrument Tip Protection Covers (K834127) received a 510(k) decision of Substantially Equivalent on February 17, 1984, 80 days after the submission was received.
What is the product code of K834127?
The FDA product code is LXZ – Guard, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.