FDA applicant

Peak Surgical, Inc.

Palo Alto, CA7 decisions2008–20111 recall

FDA records 7 decisions for Peak Surgical, Inc. (Palo Alto, CA) from 2008 to 2011: 7 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 17 predicates, 7 of them its own earlier devices. 1 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 Peak Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008high 3 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2009

2008high 1 (2009) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Peak Surgical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Peak Surgical, Inc.’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 “Peak”

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

Peak Performance Technologies, Inc. 1

Peak Surgical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Peak”