510(k) K173495
K173495 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Hot Biopsy Forceps FD-231". The FDA issued a decision of Substantially Equivalent on November 30, 2018. The device falls under product code QEC (Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree), a Class II device regulated under 21 CFR 876.4300. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2018
- Date Received
- November 13, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- AN
- Submission Type
An endoscopic electrosurgical forceps and accessories used with an endoscope to electrosurgically collect tissue for biopsy and to perform electrosurgical hemostasis within the tracheobronchial tree