Xenocor, Inc.: FDA clearances and approvals
Xenocor, Inc. has 5 FDA 510(k) clearances (first 2016, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time: 26 days. Since 2017 its median was 25 days, against 93 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 83 |
| 2017 | 1 | 24 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 59 |
| 2021 | 0 | — |
| 2022 | 1 | 26 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 22 |
Review time against the same product codes
Since 2017, Xenocor, Inc.'s cleared 510(k)s took a median 25 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
Review panels
Most recent Xenocor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260177 | Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | GCJ | 2026-02-12 | 22 |
| K220872 | Saberscope5 Laparoscope | GCJ | 2022-04-20 | 26 |
| K193315 | Xenocor Articulating Xenoscope Laparoscope | GCJ | 2020-01-27 | 59 |
| K171344 | Xenocor Xenoscope Laparoscopic System | GCJ | 2017-06-01 | 24 |
| K161838 | Xenocor Xenoscope Laparoscopic System | GCJ | 2016-09-26 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Xenocor, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Xenocor, Inc. have?
Xenocor, Inc. has 5 FDA 510(k) clearances (first 2016, latest 2026), across 1 product code in 1 review panel.
How long does FDA take to clear Xenocor, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Xenocor, Inc.'s cleared 510(k)s is 26 days. Since 2017: 25 days, versus 93 days for all cleared 510(k)s in the same product codes.
What devices does Xenocor, Inc. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 5).
Has Xenocor, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Xenocor, Inc. Related entities may recall under other names.
Next steps
- See all 5 Xenocor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Xenocor, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.