510(k) Report

FDA applicant

Surgimark, Inc.

Yakima, WA3 decisions1987–19950 recalls

FDA records 3 decisions for Surgimark, Inc. (Yakima, WA) from 1987 to 1995: 3 510(k) clearances. Most are in product codes JOL (Catheter And Tip, Suction) and HET (Laparoscope, Gynecologic (And Accessories)). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Surgimark, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Surgimark, 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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