Ulnar Nerve Protector
FDA 510(k) K840421 · Devon Industries, Inc.
510(k) numberK840421
Submission
- Device name
- Ulnar Nerve Protector
- Applicant
- Devon Industries, Inc.
Mchenry, IL, US - Received
- January 31, 1984
- Decision date
- March 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWZ – Operating Room Accessories Table Tray
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
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 FWZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960019 | Retractor Arm ClampFWZ · Traditional | Biopsys Medical, Inc. | 02/09/1996SE |
| K945415 | 'Lil Mac Accessory Clamp(Tm)FWZ · Traditional | D.L. Nelson and Assoc., Inc. | 11/22/1994SE |
| K944779 | Carbon Lights Hand Surgery TableFWZ · Traditional | Allen Medical Systems, Inc. | 10/14/1994SE |
| K935381 | Kaps Positioning ArmFWZ · Traditional | Andronic Devices, Ltd. | 04/15/1994SE |
| K931037 | Whitmore Vacuum-Lock Spinal Frame (VLSF-100)FWZ · Traditional | Whitmore Ent., Inc. | 07/30/1993SE |
| K926225 | Sponge CounterFWZ · Traditional | American Medical Manufacturer, Inc. | 03/05/1993SE |
| K925035 | Midkiff Geostatic ClampFWZ · Traditional | D.L. Nelson and Assoc., Inc. | 02/18/1993SE |
| K905565 | Lateral Buttress SupportFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K905564 | Prep and Operating StandFWZ · Traditional | Mcconnell Orthopedic | 02/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | Orthopedic Systems, Inc. | 01/24/1991SE |
More from Orthopedic Systems, Inc.
| 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 Ulnar Nerve Protector cleared by the FDA?
Ulnar Nerve Protector (K840421) received a 510(k) decision of Substantially Equivalent on March 12, 1984, 41 days after the submission was received.
What is the product code of K840421?
The FDA product code is FWZ – Operating Room Accessories Table Tray, a Class I (low risk) device regulated under 21 CFR 878.4950.