Origami Surgical, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Origami Surgical, LLC” (first 2013, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. Since 2017 the median was 134 days, against 126 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 268 |
| 2014 | 1 | 90 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 134 |
| 2019 | 1 | 58 |
| 2020 | 0 | — |
| 2021 | 2 | 91 |
| 2022 | 0 | — |
| 2023 | 1 | 264 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Origami Surgical, LLC took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 4 | 4 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 2 | 2 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
Review panels
Most recent Origami Surgical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221527 | StitchKit | GAM | 2023-02-14 | 264 |
| K211792 | StitchKit | GAM | 2021-07-16 | 36 |
| K202950 | StitchKit COMBO | GAM | 2021-02-23 | 146 |
| K191317 | StitchKit | NBY | 2019-07-12 | 58 |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | GAM | 2018-05-04 | 134 |
| K142639 | StitchKit | GAW | 2014-12-16 | 90 |
| K123811 | STITCHKIT | NBY | 2013-09-05 | 268 |
Recalls
openFDA lists no recalls under a recalling firm named Origami Surgical, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Origami Surgical, LLC?
FDA lists 7 510(k) clearances under the applicant name “Origami Surgical, LLC” (first 2013, latest 2023), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Origami Surgical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Origami Surgical, LLC is 134 days. Since 2017: 134 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Origami Surgical, LLC?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 4); NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene, 2); GAW (Suture, Nonabsorbable, Synthetic, Polypropylene, 1).
Next steps
- See all 7 Origami Surgical, LLC clearances with predicates and recalls
- Run predicate analysis for product code GAM, Origami Surgical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.