The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Endoeye Hd Ii.
| Device ID | K111788 |
| 510k Number | K111788 |
| Device Name: | ENDOEYE HD II |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | OLYMPUS AMERICA, INC. 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Stacy Abbatiello Kluesner |
| Correspondent | Stacy Abbatiello Kluesner OLYMPUS AMERICA, INC. 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-24 |
| Decision Date | 2012-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761075015 | K111788 | 000 |
| 04042761075008 | K111788 | 000 |
| 04042761074971 | K111788 | 000 |
| 04042761074964 | K111788 | 000 |