Xintec Corporation: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Xintec Corporation” (first 1990, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 124 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 26 | 26 |
Review panels
Most recent Xintec Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082230 | VECTRA PLUS LASER SYSTEM AND ACCESSORIES | GEX | 2010-02-03 | 545 |
| K990914 | POLARIS DIODE LASER SYSTEM AND ACCESSORIES | GEX | 1999-07-30 | 134 |
| K981627 | PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) | GEX | 1998-07-31 | 85 |
| K981350 | ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES | GEX | 1998-07-09 | 86 |
| K971912 | PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES | GEX | 1997-11-03 | 206 |
| K971065 | DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES | GEX | 1997-06-17 | 85 |
| K951935 | PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | GEX | 1996-03-25 | 335 |
| K951876 | PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES | GEX | 1996-03-25 | 339 |
| K951910 | ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | GEX | 1995-12-27 | 247 |
| K951760 | OPTILITE VIII LASER SURGERY ACCESSORIES | GEX | 1995-11-29 | 226 |
16 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2017-10-29.
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.
- Xintec Corporation, Dba, (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xintec Corporation?
FDA lists 26 510(k) clearances under the applicant name “Xintec Corporation” (first 1990, latest 2010), across 1 product code 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 Xintec Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xintec Corporation is 124 days.
Which FDA product codes appear under Xintec Corporation?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 26).
Next steps
- See all 26 Xintec Corporation clearances with predicates and recalls
- Run predicate analysis for product code GEX, Xintec Corporation'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.