Kaps Positioning Arm
FDA 510(k) K935381 · Andronic Devices, Ltd.
510(k) numberK935381
Submission
- Device name
- Kaps Positioning Arm
- Applicant
- Andronic Devices, Ltd.
Richmond,B.C. Canada, CA - Received
- November 8, 1993
- Decision date
- April 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K904826 | Tko Telescoping Lithotomy StirrupFWZ · Traditional | D.L. Nelson and Assoc., Inc. | 10/31/1990SE |
More from D.L. Nelson and Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940812 | Insight Electronic Alignment IndicatorKQX · Traditional | 11/21/1994SE |
| K934928 | Insite Filter & Tubing SetHIF · Traditional | 05/26/1994SE |
| K934926 | Insite Model 20 & Model 15 InsufflatorsHIF · Traditional | 05/26/1994SE |
| K934124 | Autoquot Automated Aliquotting SystemJQW · Traditional | 04/13/1994SE |
| K936308 | Endex Endoscopic Positioning SystemFQO · Traditional | 03/31/1994SE |
| K932253 | Arthrobot Bi-Fold DrapeKKX · Traditional | 02/03/1994SE |
| K922626 | Adept Instrument Positioning AccessoryGAD · Traditional | 10/19/1992SE |
| K922625 | Adept Endoscopic PositionerGAD · Traditional | 10/19/1992SE |
| K911521 | Arthrobot(Tm) 96 (240 CM) Drape with 1 StrapKKX · Traditional | 08/02/1991SE |
| K911520 | Arthrobot(Tm) 75 (190 CM) General Purpose DrapeKKX · Traditional | 08/02/1991SE |
Questions and answers
When was Kaps Positioning Arm cleared by the FDA?
Kaps Positioning Arm (K935381) received a 510(k) decision of Substantially Equivalent on April 15, 1994, 158 days after the submission was received.
What is the product code of K935381?
The FDA product code is FWZ – Operating Room Accessories Table Tray, a Class I (low risk) device regulated under 21 CFR 878.4950.