K942677 is an FDA 510(k) clearance for the GEENEN/ZEBRA GUIDELINES. This device is classified as a Laparoscopy Kit (Class II - Special Controls, product code FDE).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on July 21, 1994, 44 days after receiving the submission on June 7, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. 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 | K942677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1994 |
| Decision Date | July 21, 1994 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDE — Laparoscopy Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| 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. |