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Stingray Surgical Products: FDA-registered device maker in Boca Raton, FL, United States, 2 510(k) clearances

Name: Stingray Surgical Products FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Stingray Surgical Products is registered with the FDA (registration 3006059917) in Boca Raton, FL, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 10, 2013. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006059917
Address: 1701 Costa Del Sol, Boca Raton, FL, United States, 33432
Owner or operator: Stingray Surgical Products (10026274)
Roles: Manufacturer, Remanufacturer, Repackager or relabeler
First device listed: February 21, 2011
Registered through: 2027
Brand names listed: Eco-Friendly Forceps, Stingray Instrument Trays, Stingray Instruments, Stingray Leep /Lletz Forceps, Stingray Leep/ Lletz Speculum, Stingray bipolar forceps

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Remanufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Remanufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 10, 2013	K123478	STINGRAY BIPOLAR FORCEPS	GEI	Substantially Equivalent	Stingray Surgical Products	accessdata.fda.gov
September 19, 1997	K972901	AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD	GEI	Substantially Equivalent	American Biosurgical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 23, 2012	62024	Class II	Terminated	Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagula	On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use". The sterilization instructions have been altered without the clearance of the FDA.	accessdata.fda.gov

Compare with other makers

Updated May 10, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.