The following data is part of a premarket notification filed by Surgical Specialties Corp. Dba Angiotech with the FDA for Quill Monoderm Knotless Tissue-closure Device, Variable Loop Design.
| Device ID | K122898 |
| 510k Number | K122898 |
| Device Name: | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading, PA 19606 |
| Contact | Kirsten Stowell |
| Correspondent | Kirsten Stowell SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading, PA 19606 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-21 |
| Decision Date | 2012-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782030603 | K122898 | 000 |
| 10848782020031 | K122898 | 000 |
| 10848782020093 | K122898 | 000 |
| 10848782020116 | K122898 | 000 |
| 10848782020345 | K122898 | 000 |
| 10848782020406 | K122898 | 000 |
| 10848782020420 | K122898 | 000 |
| 10848782020482 | K122898 | 000 |
| 10848782020505 | K122898 | 000 |
| 10848782020543 | K122898 | 000 |
| 10848782030597 | K122898 | 000 |
| 10848782020017 | K122898 | 000 |