510(k) Report

FDA applicant

Xenocor, Inc.

Salt Lake City, UT5 decisions2016–20260 recalls

FDA records 5 decisions for Xenocor, Inc. (Salt Lake City, UT) from 2016 to 2026: 5 510(k) clearances. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 26 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Xenocor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 12017: 12020: 12022: 12026 (partial year): 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Xenocor, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xenocor, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 26 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 5 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161838Xenocor Xenoscope Laparoscopic SystemXenocor, Inc. · 20163cite it
  • K220872Saberscope5 LaparoscopeXenocor, Inc. · 20222cite it
  • K193315Xenocor Articulating Xenoscope LaparoscopeXenocor, Inc. · 20201cites it

What has FDA decided for it lately?

  • K260177Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)Xenocor, Inc. · 2026
  • K220872Saberscope5 LaparoscopeXenocor, Inc. · 2022
  • K193315Xenocor Articulating Xenoscope LaparoscopeXenocor, Inc. · 2020
  • K171344Xenocor Xenoscope Laparoscopic SystemXenocor, Inc. · 2017
  • K161838Xenocor Xenoscope Laparoscopic SystemXenocor, Inc. · 2016

All 5 as Xenocor, Inc. →