FDA applicant

Prosurg, Inc.

San Jose, CA16 decisions2000–20160 recalls

FDA records 16 decisions for Prosurg, Inc. (San Jose, CA) from 2000 to 2016: 16 510(k) clearances. Most are in product codes FAJ (Cystoscope And Accessories, Flexible/Rigid) and JEY (Plate, Bone). Since 2016 its 510(k)s took a median of 262 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 13 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 Prosurg, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2016

2007high 4 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prosurg, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Prosurg, 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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Prosurg, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?