510(k) K033578
K033578 is an FDA 510(k) premarket notification submitted by Clearmedical, Inc. for the device "REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS". The FDA issued a decision of Substantially Equivalent on July 11, 2005. The device falls under product code NLL (Staple, Implantable, Reprocessed), a Class II device regulated under 21 CFR 878.4750. Clearmedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2005
- Date Received
- November 13, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable, Reprocessed
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).