The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Grasping Forceps Fg-214p, Single Use Grasping Forceps Fg-220p, Single Use Grasping Forceps Fg-226c, Single Use Grasping Forceps Fg-232l, Single Use Grasping Forceps Fg-804l.
| Device ID | K200342 |
| 510k Number | K200342 |
| Device Name: | Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuki Nakajima |
| Correspondent | Sheri L Musgnung Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-11 |
| Decision Date | 2020-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170435871 | K200342 | 000 |
| 14953170435864 | K200342 | 000 |
| 14953170435857 | K200342 | 000 |
| 14953170435840 | K200342 | 000 |
| 14953170435833 | K200342 | 000 |