Scion Medical Technologies, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Scion Medical Technologies, LLC” (first 2013, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 48 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 |
|---|---|---|
| 2013 | 2 | 74 |
| 2014 | 1 | 48 |
| 2015 | 1 | 44 |
| 2016 | 1 | 93 |
| 2017 | 1 | 30 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Scion Medical Technologies, LLC took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | 4 | 4 |
| KNW | Instrument, Biopsy | 2 | 2 |
Review panels
Most recent Scion Medical Technologies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170905 | Star Tissue Marker | NEU | 2017-04-27 | 30 |
| K161234 | CASSI II Rotational Core Biopsy System | KNW | 2016-08-03 | 93 |
| K153189 | Beacon Tissue Marker (SE) | NEU | 2015-12-17 | 44 |
| K140835 | GENERAL AND PLASTIC SURGERY | NEU | 2014-05-20 | 48 |
| K130763 | BEACON TISSUE MARKER | NEU | 2013-05-08 | 49 |
| K123606 | CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE | KNW | 2013-03-01 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Scion Medical Technologies, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Scion Medical Technologies, LLC (a text match, not an official crosswalk):
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.
- Scion Cardio-Vascular, Inc. (4 510(k)s)
- Scion International, Inc. (4 510(k)s)
- Scion Cardiovascular, Inc. (1 510(k)s)
- Scion Valley, Inc. (1 510(k)s)
- Scion Neurostim, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scion Medical Technologies, LLC?
FDA lists 6 510(k) clearances under the applicant name “Scion Medical Technologies, LLC” (first 2013, latest 2017), across 2 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 Scion Medical Technologies, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scion Medical Technologies, LLC is 48 days.
Which FDA product codes appear under Scion Medical Technologies, LLC?
The most frequent FDA product codes under this applicant name are NEU (Marker, Radiographic, Implantable, 4); KNW (Instrument, Biopsy, 2).
Next steps
- See all 6 Scion Medical Technologies, LLC clearances with predicates and recalls
- Run predicate analysis for product code NEU, Scion Medical Technologies, 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.