K960019 is an FDA 510(k) clearance for the RETRACTOR ARM CLAMP. This device is classified as a Operating Room Accessories Table Tray (Class I — General Controls, product code FWZ).
Submitted by Biopsys Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 9, 1996, 38 days after receiving the submission on January 2, 1996.
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 | K960019 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 02, 1996 |
| Decision Date | February 09, 1996 |
| Days to Decision | 38 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. |