Submission Details
| 510(k) Number | K190744 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 2019 |
| Decision Date | August 29, 2019 |
| Days to Decision | 160 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Special
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Aug 2019
Decision
160d
Days
Class 2
Risk
About This 510(k) Submission
K190744 is an FDA 510(k) clearance for the ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A), a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on August 29, 2019, 160 days after receiving the submission on March 22, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.
Device Classification
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1720 |
Manufacturer
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