Parcus Medical, LLC: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Parcus Medical, LLC” (first 2009, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Since 2017 the median was 65 days, against 88 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 |
|---|---|---|
| 2012 | 2 | 26 |
| 2013 | 1 | 145 |
| 2014 | 1 | 55 |
| 2015 | 1 | 60 |
| 2016 | 1 | 105 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 6 | 65 |
| 2020 | 4 | 85 |
| 2021 | 2 | 99 |
| 2022 | 2 | 47 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Parcus Medical, LLC took a median 65 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 21 | 21 |
| HWC | Screw, Fixation, Bone | 5 | 5 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 2 |
Review panels
- Orthopedic (28)
Most recent Parcus Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221502 | Parcus Synd-EZ SS | MBI | 2022-07-26 | 64 |
| K221135 | X-Twist PEEK Suture Anchor | MBI | 2022-05-19 | 30 |
| K212739 | ActiFlip | MBI | 2021-10-06 | 37 |
| K202662 | Parcus Titanium Interference Screws | MBI | 2021-02-22 | 161 |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip | MBI | 2020-10-28 | 79 |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | MBI | 2020-07-23 | 91 |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | MBI | 2020-01-23 | 57 |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | MBI | 2020-01-16 | 108 |
| K192964 | Parcus Synd-EZ SS | MBI | 2019-11-22 | 30 |
| K192824 | Parcus Knotless AP Suture Anchors | MAI | 2019-11-02 | 31 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Parcus Medical, 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.
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.
- Parcus Medical (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Parcus Medical, LLC?
FDA lists 28 510(k) clearances under the applicant name “Parcus Medical, LLC” (first 2009, latest 2022), 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 Parcus Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Parcus Medical, LLC is 84 days. Since 2017: 65 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Parcus Medical, LLC?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 21); HWC (Screw, Fixation, Bone, 5); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 2).
Next steps
- See all 28 Parcus Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code MBI, Parcus Medical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.