ORIGAMI SURGICAL Inc.
Dover, MA, US
ORIGAMI SURGICAL Inc. appears in FDA device records in Dover, MA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for ORIGAMI SURGICAL Inc. between 2013 and 2023. The busiest year on record is 2021, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221527 | StitchKit | GAM | Substantially Equivalent | |
| K211792 | StitchKit | GAM | Substantially Equivalent | |
| K202950 | StitchKit COMBO | GAM | Substantially Equivalent | |
| K191317 | StitchKit | NBY | Substantially Equivalent | |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | GAM | Substantially Equivalent | |
| K142639 | StitchKit | GAW | Substantially Equivalent | |
| K123811 | STITCHKIT | NBY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010860245 | 3010860245 | ORIGAMI SURGICAL Inc. | 79 Haven St., Dover, MA 02030 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCJLaparoscope, General & Plastic Surgery
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- NAYSystem, Surgical, Computer Controlled Instrument
- FSHTray, Surgical, Needle
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain