The following data is part of a premarket notification filed by Surgical Specialties Corporation with the FDA for Quill Monoderm Knotless Tissue-closure Device, Variable Loop Design.
| Device ID | K141778 |
| 510k Number | K141778 |
| Device Name: | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SURGICAL SPECIALTIES CORPORATION 100 DENNIS DRIVE Reading, PA 19606 |
| Contact | Kirsten Stowell Franco |
| Correspondent | Kirsten Stowell Franco SURGICAL SPECIALTIES CORPORATION 100 DENNIS DRIVE 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 | 2014-07-02 |
| Decision Date | 2014-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782020536 | K141778 | 000 |
| 10848782020529 | K141778 | 000 |
| 10848782040060 | K141778 | 000 |
| 10848782004772 | K141778 | 000 |