StitchKit
Suture, Absorbable, Synthetic, Polyglycolic Acid
Origami Surgical Inc .
The following data is part of a premarket notification filed by Origami Surgical Inc . with the FDA for Stitchkit.
Pre-market Notification Details
| Device ID | K211792 |
| 510k Number | K211792 |
| Device Name: | StitchKit |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Origami Surgical Inc . 42 Main St. Madison, NJ 07940 |
| Contact | John Gillespie |
| Correspondent | John Gillespie Origami Surgical Inc . 42 Main St. Madison, NJ 07940 |
| Product Code | GAM |
| Subsequent Product Code | GAT |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | NAY |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-10 |
| Decision Date | 2021-07-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004977353 | K211792 | 000 |
| 00860004977346 | K211792 | 000 |
| 00860004977339 | K211792 | 000 |
| 10860004977312 | K211792 | 000 |
| 10860004977305 | K211792 | 000 |
| 10860004977381 | K211792 | 000 |
| 10860004977374 | K211792 | 000 |
| 00860004977322 | K211792 | 000 |
Trademark Results [StitchKit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STITCHKIT 85662513 4286173 Live/Registered |
Origami Surgical, LLC 2012-06-27 |
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