The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Spies 3d Tip Cam, Image 1 Spies Ccu Image Connect, Image 1 Spies Ccu D-3 Link.
| Device ID | K150525 |
| 510k Number | K150525 |
| Device Name: | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE El Segundo, CA 90245 |
| Contact | Susie S. Chen |
| Correspondent | Winkie S. Wong KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E.GRAND AVE El Segundo, CA 90245 |
| Product Code | HET |
| Subsequent Product Code | FGB |
| Subsequent Product Code | GCJ |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551347843 | K150525 | 000 |
| 04048551347782 | K150525 | 000 |