K892389 is an FDA 510(k) clearance for the BIOPSY KIT. This device is classified as a General Surgery Tray (Class II - Special Controls, product code LRO).
Submitted by I M, Inc. (Fairfield, US). The FDA issued a Cleared decision on July 17, 1989, 101 days after receiving the submission on April 7, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4370. 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 | K892389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | April 07, 1989 |
| Decision Date | July 17, 1989 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | LRO — General Surgery Tray |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |
| 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 |