K173495 is an FDA 510(k) clearance for the Single Use Hot Biopsy Forceps FD-231. This device is classified as a Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree (Class II - Special Controls, product code QEC).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on November 30, 2018, 382 days after receiving the submission on November 13, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 876.4300. 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.
| 510(k) Number | K173495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2017 |
| Decision Date | November 30, 2018 |
| Days to Decision | 382 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | QEC — Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |
| Definition | 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 |