The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Ncircle(r) Nitinol Tipless Stone Extractor Ngage(r) Nitinol Stone Extractor.
| Device ID | K120468 |
| 510k Number | K120468 |
| Device Name: | NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Susanne Galin |
| Correspondent | Susanne Galin COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-16 |
| Decision Date | 2012-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850007350376 | K120468 | 000 |
| 00850007350369 | K120468 | 000 |