510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Stingray Surgical Products

Boca Raton, FL, US

STINGRAY SURGICAL PRODUCTS appears in FDA device records in Boca Raton, FL. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Stingray Surgical Products between 2009 and 2013. The busiest year on record is 2009, with 1. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for Stingray Surgical Products, by decision year
YearClearances
20091
20111
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K123478STINGRAY BIPOLAR FORCEPSGEISubstantially Equivalent
K102752STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPSGEISubstantially Equivalent
K083162STINGRAY ELECTROSURGICAL FORCEPSGEISubstantially Equivalent

Registered establishments

FDA registered establishments for Stingray Surgical Products, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30060599173006059917STINGRAY SURGICAL PRODUCTS1701 Costa Del Sol, Boca Raton, FL 33432 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2011-2012Bipolar 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 coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.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.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain