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 | K123409 |
| 510k Number | K123409 |
| 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 | 2012-11-05 |
| Decision Date | 2012-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782020390 | K123409 | 000 |
| 10848782020079 | K123409 | 000 |
| 10848782020239 | K123409 | 000 |
| 10848782020253 | K123409 | 000 |
| 10848782020277 | K123409 | 000 |
| 10848782020291 | K123409 | 000 |
| 10848782020314 | K123409 | 000 |
| 10848782020338 | K123409 | 000 |
| 10848782020352 | K123409 | 000 |
| 10848782020369 | K123409 | 000 |
| 10848782020376 | K123409 | 000 |
| 10848782020383 | K123409 | 000 |
| 10848782020055 | K123409 | 000 |