510(k) Report

FDA applicant

Precision Surgical Instrument, Inc.

Rockland, MA3 decisions1985–19850 recalls

FDA records 3 decisions for Precision Surgical Instrument, Inc. (Rockland, MA) in 1985: 3 510(k) clearances. All are in product code KNA (Instrument, Manual, Specialized…). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Precision Surgical Instrument, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Precision Surgical Instrument, 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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