The following data is part of a premarket notification filed by Carefusion 2200, Inc. with the FDA for Diamond-flex(r) Graspers.
| Device ID | K110257 |
| 510k Number | K110257 |
| Device Name: | DIAMOND-FLEX(R) GRASPERS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CAREFUSION 2200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Jane Weber |
| Correspondent | Jane Weber CAREFUSION 2200, INC. 1500 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-28 |
| Decision Date | 2011-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885403155598 | K110257 | 000 |
| 10885403181856 | K110257 | 000 |
| 10885403181832 | K110257 | 000 |
| 10885403181825 | K110257 | 000 |
| 10885403181818 | K110257 | 000 |
| 10885403181801 | K110257 | 000 |
| 10885403181795 | K110257 | 000 |
| 10885403181788 | K110257 | 000 |
| 10885403181771 | K110257 | 000 |
| 10885403181764 | K110257 | 000 |
| 10885403183287 | K110257 | 000 |
| 10885403155482 | K110257 | 000 |
| 10885403155499 | K110257 | 000 |
| 10885403155581 | K110257 | 000 |
| 10885403155574 | K110257 | 000 |
| 10885403155567 | K110257 | 000 |
| 10885403155550 | K110257 | 000 |
| 10885403155543 | K110257 | 000 |
| 10885403155536 | K110257 | 000 |
| 10885403155529 | K110257 | 000 |
| 10885403155512 | K110257 | 000 |
| 10885403155505 | K110257 | 000 |
| 10885403181757 | K110257 | 000 |