510(k) Report

FDA applicant

Pelvalon

Hillsborough, CA2 decisions2015–20150 recalls

FDA records 2 decisions for Pelvalon (Hillsborough, CA) in 2015: 1 510(k) clearance and 1 De Novo grant. All are in product code PJH (Dynamic Rectal Control System). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Pelvalon, Inc.”.

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 Pelvalon’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015: 2
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Pelvalon by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • PJHDynamic Rectal Control System2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN140020Eclipse SystemPelvalon · 20151cites it

What has FDA decided for it lately?

  • K150558Eclipse SystemPelvalon, Inc. · 2015
  • DEN140020Eclipse SystemPelvalon · 2015

The one decision as Pelvalon →The one decision as Pelvalon, Inc. →