FDA applicant

Prescient Surgical

San Carlos, CA2 decisions2016–20170 recalls

FDA records 2 decisions for Prescient Surgical (San Carlos, CA) from 2016 to 2017: 1 510(k) clearance and 1 De Novo grant. All are in product code PQI (Wound Retraction And Protection System). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Prescient Surgical, Inc.”.

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 Prescient Surgical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Prescient Surgical by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Prescient Surgical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Prescient”

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

Prescient Imaging, LLC 1

Prescient Surgical

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Prescient”