510(k) K050136
K050136 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED HOT BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on July 20, 2005. The device falls under product code NLU (Forceps, Biopsy, Electric, Reprocessed), a Class II device regulated under 21 CFR 876.4300. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2005
- Date Received
- January 21, 2005
- 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).