The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Sheath, Stopcock Accessory.
| Device ID | K213207 |
| 510k Number | K213207 |
| Device Name: | Sheath, Stopcock Accessory |
| Classification | Hysteroscope (and Accessories) |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg, DE 22045 |
| Contact | Katharina Campbell |
| Correspondent | Jonathan Gilbert Olympus Corporation Of The Americas (OCA) 3500 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2021-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761085915 | K213207 | 000 |