510(k) Report

FDA applicant

Scholten Surgical Instruments, Inc.

Redwood City, CA8 decisions1985–20070 recalls

FDA records 8 decisions for Scholten Surgical Instruments, Inc. (Redwood City, CA) from 1985 to 2007: 8 510(k) clearances. Most are in product codes JEB (Table, Surgical With Orthopedic Accessories…) and GAD (Retractor). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Scholten Surgical Instruments, 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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