Opus Medical, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Opus Medical, Inc.” (first 2001, latest 2004), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | 4 | 4 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
Most recent Opus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER | HWC | 2004-12-14 | 83 |
| K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE | MBI | 2004-11-12 | 22 |
| K042031 | OPUS SPEEDSTITCH SUTURE DEVICE | GAT | 2004-10-19 | 83 |
| K041440 | OPUS MAGNUM ANCHOR WITH INSERTER | MBI | 2004-06-25 | 24 |
| K033317 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 | OCW | 2003-12-30 | 76 |
| K030170 | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 | OCW | 2003-07-28 | 192 |
| K031083 | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 | HTY | 2003-06-12 | 69 |
| K030235 | F1 DIODE LASER SYSTEM | GEX | 2003-04-23 | 90 |
| K023843 | SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE | OCW | 2003-02-14 | 88 |
| K022229 | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 | OCW | 2002-09-06 | 58 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Opus Medical, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Opus Ksd, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Opus Medical, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Opus Medical, Inc.” (first 2001, latest 2004), across 6 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 Opus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Opus Medical, Inc. is 83 days.
Which FDA product codes appear under Opus Medical, Inc.?
The most frequent FDA product codes under this applicant name are OCW (Endoscopic Tissue Approximation Device, 4); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 3); GEX (Powered Laser Surgical Instrument, 2).
Next steps
- See all 13 Opus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCW, Opus Medical, 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.