The following data is part of a premarket notification filed by Origami Surgical Llc with the FDA for Stitchkit V-loc 90, Stitchkit V-loc 180, Stitchkit Quill Pdo.
| Device ID | K173874 |
| 510k Number | K173874 |
| Device Name: | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Origami Surgical LLC 42 Main St. Suite A Madison, NJ 07945 |
| Contact | John Gillespie |
| Correspondent | John Gillespie Clover Medical LLC 79 Haven St. Dover, MA 02030 |
| Product Code | GAM |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | NAY |
| Subsequent Product Code | NEW |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2018-05-04 |
| Summary: | summary |