The following data is part of a premarket notification filed by Surgical Specialties Corporation Dba Angiotech with the FDA for Quill Pdo Knotless Tissue-closure Device, Variable Loop Design.
| Device ID | K132268 |
| 510k Number | K132268 |
| Device Name: | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | SURGICAL SPECIALTIES CORPORATION DBA ANGIOTECH 100 DENNIS DRIVE Reading, PA 19606 |
| Contact | Kirsten Stowell |
| Correspondent | Kirsten Stowell SURGICAL SPECIALTIES CORPORATION DBA ANGIOTECH 100 DENNIS DRIVE Reading, PA 19606 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-22 |
| Decision Date | 2013-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782020871 | K132268 | 000 |
| 10848782000255 | K132268 | 000 |
| 10848782000248 | K132268 | 000 |
| 10848782000231 | K132268 | 000 |
| 10848782000224 | K132268 | 000 |
| 10848782000217 | K132268 | 000 |
| 10848782000200 | K132268 | 000 |
| 10848782000170 | K132268 | 000 |
| 10848782040152 | K132268 | 000 |
| 10848782040145 | K132268 | 000 |
| 10848782040138 | K132268 | 000 |
| 10848782040121 | K132268 | 000 |
| 10848782040114 | K132268 | 000 |
| 10848782040107 | K132268 | 000 |
| 10848782040091 | K132268 | 000 |
| 10848782040084 | K132268 | 000 |
| 10848782000323 | K132268 | 000 |
| 10848782000330 | K132268 | 000 |
| 10848782020864 | K132268 | 000 |
| 10848782020857 | K132268 | 000 |
| 10848782020840 | K132268 | 000 |
| 10848782020802 | K132268 | 000 |
| 10848782020789 | K132268 | 000 |
| 10848782004802 | K132268 | 000 |
| 10848782000453 | K132268 | 000 |
| 10848782000446 | K132268 | 000 |
| 10848782000439 | K132268 | 000 |
| 10848782000422 | K132268 | 000 |
| 10848782000415 | K132268 | 000 |
| 10848782000408 | K132268 | 000 |
| 10848782000392 | K132268 | 000 |
| 10848782000354 | K132268 | 000 |
| 10848782000347 | K132268 | 000 |
| 10848782040077 | K132268 | 000 |