FDA applicant

Suros Surgical Systems, Inc.

Indianapolis, IN3 decisions2004–20074 recalls

FDA records 3 decisions for Suros Surgical Systems, Inc. (Indianapolis, IN) from 2004 to 2007: 3 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and NEU (Marker, Radiographic, Implantable). 4 recalls are 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 Suros Surgical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2010

2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Suros Surgical Systems, Inc.’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

Other applicant names beginning “Suros”

FDA records each applicant name separately; these may or may not be the same firm.

Suros Surgical Systems, Inc. A Hologic Company 2

Suros Surgical Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Suros”