510(k) Report

FDA applicant

Stingray Surgical Products, Inc.

Boca Raton, FL3 decisions2009–20131 recall

FDA records 3 decisions for Stingray Surgical Products, Inc. (Boca Raton, FL) from 2009 to 2013: 3 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 4 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Stingray Surgical Products”.

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 Stingray Surgical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 12011: 12013: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2009high 1 (2012) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Stingray Surgical Products, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stingray Surgical Products, 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

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K083162Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 20093cite it

What has FDA decided for it lately?

  • K123478Stingray Bipolar ForcepsStingray Surgical Products · 2013
  • K102752Stingray Ultralite Disposable Irrigating Bipolar ForcepsStingray Surgical Products, Inc. · 2011
  • K083162Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 20091 recall

All 2 as Stingray Surgical Products, Inc. →The one decision as Stingray Surgical Products →

What has been recalled?

1 recall linked to its devices; the latest:

  • K083162Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For…May 23, 2012Class II