510(k) Report

FDA applicant

Srs Medical

North Billerica2 decisions2006–20210 recalls

FDA records 2 decisions for Srs Medical (North Billerica) from 2006 to 2021: 1 510(k) clearance and 1 original PMA approval. Most are in product codes NZC (Stent, Urethral, Prostatic, Semi-Permanent) and FEN (Device, Cystometric, Hydraulic). Its devices cite 1 predicate, 0 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 Srs Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • NZCStent, Urethral, Prostatic, Semi-Permanent1decision
  • FENDevice, Cystometric, Hydraulic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K212830CT3000ProSrs Medical · 2021
  • P060010The Spanner Temporary Prostatic StentSrs Medical · 2006

All 2 as Srs Medical →