510(k) K173495
- Device
- Single Use Hot Biopsy Forceps FD-231
- Applicant
- Olympus Medical Systems Corp.
- 510(k) number
- K173495
- Product code
- QEC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-30
- Date received
- 2017-11-13
- Regulation
- 876.4300
- Classification name
- Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Toshiyuki Nakajima
- Address
- 2951 Ishikawa-Cho Hachioji-Shi JP 192-8507 192-8507
FDA Registration Numbers#
- 3014769442
- 9614641
- 8010047
Source Documents#
Legacy Summary#
summary
FDA Review#
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