510(k) Report

FDA applicant

Davis & Geck, Inc.

Danbury, CT46 decisions1978–199915 recalls

FDA records 46 decisions for Davis & Geck, Inc. (Danbury, CT) from 1978 to 1999: 45 510(k) clearances and 1 original PMA approval. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). Its devices cite 13 predicates, 4 of them its own earlier devices. 15 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, general and plastic surgery panel, where it files most

How often FDA has decided Davis & Geck, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Davis & Geck, Inc. since 2007.

Recalls per year

1in 2026

2011: 112022: 22023: 12026 (partial year): 1
2007high 11 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Davis & Geck, Inc.’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 “Davis”

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