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 | K123836 |
| 510k Number | K123836 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-13 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782020468 | K123836 | 000 |
| 10848782020444 | K123836 | 000 |
| 10848782020215 | K123836 | 000 |
| 10848782020192 | K123836 | 000 |
| 10848782020178 | K123836 | 000 |
| 10848782020154 | K123836 | 000 |
| 10848782020130 | K123836 | 000 |