K150525 is an FDA 510(k) clearance for the SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on November 20, 2015, 263 days after receiving the submission on March 2, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K150525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2015 |
| Decision Date | November 20, 2015 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1720 |