Myocure, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Myocure, Inc.” (first 1982, latest 1988), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 32 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HNN | Knife, Ophthalmic | 5 | 5 |
| HMX | Cannula, Ophthalmic | 2 | 2 |
| FZZ | Marker, Skin | 1 | 1 |
| HMN | Suture, Nonabsorable, Ophthalmic | 1 | 1 |
| HMR | Marker, Ocular | 1 | 1 |
| HNC | Specula, Ophthalmic | 1 | 1 |
| HNY | Cystotome | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Ophthalmic (10)
- General and Plastic Surgery (2)
- Radiology (1)
Most recent Myocure, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880347 | ANESTHESIA/RETROBULBAR NEEDLES | HMX | 1988-05-03 | 98 |
| K880346 | CANNULAS | HMX | 1988-05-03 | 98 |
| K880345 | CYSTOTOMES/KNIFES | HNY | 1988-05-03 | 98 |
| K874057 | OPHTHALMIC TIP & BLADE SCALPELS | HNN | 1987-12-23 | 79 |
| K874056 | OPHTHALMIC DISPOSABLE BLADES | HNN | 1987-12-22 | 78 |
| K873385 | OPHTHALMIC PHACO-BLADE | HNN | 1987-09-21 | 28 |
| K864371 | SURGICAL SKIN MARKER | FZZ | 1986-11-17 | 12 |
| K863666 | THE SAVER KIT | — | 1986-10-20 | 32 |
| K863663 | OPHTHALMIC SURGICAL OCULAR MARKERS | HMR | 1986-10-20 | 32 |
| K863662 | OPHTHALMIC SURGICAL DRAPE | — | 1986-10-20 | 32 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Myocure, Inc..
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 Myocure, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Myocure, Inc.” (first 1982, latest 1988), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Myocure, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Myocure, Inc. is 32 days.
Which FDA product codes appear under Myocure, Inc.?
The most frequent FDA product codes under this applicant name are HNN (Knife, Ophthalmic, 5); HMX (Cannula, Ophthalmic, 2); FZZ (Marker, Skin, 1).
Next steps
- See all 15 Myocure, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNN, Myocure, Inc.'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.