510(k) K033593
K033593 is an FDA 510(k) premarket notification submitted by Clearmedical, Inc. for the device "REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on November 20, 2003. The device falls under product code NLU (Forceps, Biopsy, Electric, Reprocessed), a Class II device regulated under 21 CFR 876.4300. Clearmedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2003
- Date Received
- November 13, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Biopsy, Electric, Reprocessed
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type
The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied. This device is indicated for reuse/reprocessing. 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).