K935381 is an FDA 510(k) clearance for the KAPS POSITIONING ARM. This device is classified as a Operating Room Accessories Table Tray (Class I - General Controls, product code FWZ).
Submitted by Andronic Devices, Ltd. (Richmond,B.C. Canada, CA). The FDA issued a Cleared decision on April 15, 1994, 158 days after receiving the submission on November 8, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950. 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..
| 510(k) Number | K935381 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1993 |
| Decision Date | April 15, 1994 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FWZ — Operating Room Accessories Table Tray |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |
| Definition | 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. |