510(k) K011800
K011800 is an FDA 510(k) premarket notification submitted by Vanguard Medical Concepts, Inc. for the device "VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on September 27, 2001. The device falls under product code NLU (Forceps, Biopsy, Electric, Reprocessed), a Class II device regulated under 21 CFR 876.4300. Vanguard Medical Concepts, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2001
- Date Received
- June 8, 2001
- 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).