STITCHKIT
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
ORIGAMI SURGICAL LLC
The following data is part of a premarket notification filed by Origami Surgical Llc with the FDA for Stitchkit.
Pre-market Notification Details
| Device ID | K123811 |
| 510k Number | K123811 |
| Device Name: | STITCHKIT |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | ORIGAMI SURGICAL LLC 79 HAVEN ST. Dover, MA 02030 |
| Contact | John Gillespie |
| Correspondent | John Gillespie ORIGAMI SURGICAL LLC 79 HAVEN ST. Dover, MA 02030 |
| Product Code | NBY |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | NAY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-11 |
| Decision Date | 2013-09-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860088000206 | K123811 | 000 |
| 00860088000237 | K123811 | 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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