510(k) Report

FDA applicant

Convatec, A Division of E.R. Squibb & Sons

Princeton, NJ84 decisions1982–20093 recalls

FDA records 84 decisions for Convatec, A Division of E.R. Squibb & Sons (Princeton, NJ) from 1982 to 2009: 84 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and KMF (Bandage, Liquid). Its devices cite 6 predicates, 3 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Convatec, A Division of E.R. Squibb & Sons, LLC”.

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 Convatec, A Division of E.R. Squibb & Sons’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12008: 12009: 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Convatec, A Division of E.R. Squibb & Sons by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Convatec, A Division of E.R. Squibb &…’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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Other applicant names beginning “Convatec”

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