FDA applicant

Circon Acmi

Stamford, CT10 decisions1988–20024 recalls

FDA records 10 decisions for Circon Acmi (Stamford, CT) from 1988 to 2002: 10 510(k) clearances. Most are in product codes KNS (Unit, Electrosurgical, Endoscopic (With Or…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 5 predicates, 0 of them its own earlier devices. 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 Circon Acmi’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Circon Acmi since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Circon Acmi’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 “Circon”

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

Circon Video 14 Circon Corp. 6

Circon Acmi

Which product codes does it file in?

Whose devices does it build on?

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 “Circon”