510(k) Report

FDA applicant

Christcot Medical Company

Sudbury, MA1 decision2009–20090 recalls

FDA records 1 decision for Christcot Medical Company (Sudbury, MA) in 2009: 1 510(k) clearance. All are in product code OOW (Applicator For Rectal Suppository). 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 Christcot Medical Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Christcot Medical Company by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OOWApplicator For Rectal Suppository1decision

What has FDA decided for it lately?

  • K092829InserteaseChristcot Medical Company · 2009

The one decision as Christcot Medical Company →