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

Redwood City, CA, US

Laurimed, LLC appears in FDA device records in Redwood City, CA. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 8 510(k) clearances for Laurimed, LLC between 2008 and 2017. The busiest year on record is 2009, with 3. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for Laurimed, LLC, by decision year
YearClearances
20082
20093
20131
20161
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderERLSubstantially Equivalent
K161101PolypVac Microdebrider (3.3mm and 4.0mm)ERLSubstantially Equivalent
K133133LAURIMED POLYPVAC MICRODEBRIDERERLSubstantially Equivalent
K091818LAURIMED SPINAL INJECTION SYSTEMBSPSubstantially Equivalent
K090815PERCUTANEOUS DISCECTOMY SYSTEMHRXSubstantially Equivalent
K083909SPINAL INJECTION SYSTEMBSPSubstantially Equivalent
K082194LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002HRXSubstantially Equivalent
K080140LAURIMED SPINAL INJECTION SYSTEMBSPSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1527-2014PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.Class IIITerminated

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