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

West Lafayette, IN, US

Cook Biotech Incorporated appears in FDA device records in West Lafayette, IN. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 16 510(k) clearances for Cook Biotech Incorporated between 2013 and 2024. The busiest year on record is 2016, with 5. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cook Biotech Incorporated, by decision year
YearClearances
20131
20141
20151
20165
20174
20181
20191
20201
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)KHJSubstantially Equivalent
K201000Biodesign Staple Line ReinforcementFTMSubstantially Equivalent
K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftOXNSubstantially Equivalent
K171817Biodesign Diaphragmatic Hernia GraftFTMSubstantially Equivalent
K162934Biodesign Parastomal Hernia Repair GraftFTMSubstantially Equivalent
K170016Biodesign Fistula PlugFTMSubstantially Equivalent
K170945Biodesign Staple Line ReinforcementOXESubstantially Equivalent
K161762DynaMatrix/Dynamatrix PlusNPLSubstantially Equivalent
K162741AxoGuard Nerve ConnectorJXISubstantially Equivalent
K160136Flowable Wound MatrixKGNSubstantially Equivalent
K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugFTMSubstantially Equivalent
K161000Biodesign Otologic Repair GraftKHJSubstantially Equivalent
K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftFTMSubstantially Equivalent
K152033Cook ECM PowderKGNSubstantially Equivalent
K132660NERVE CUFFJXISubstantially Equivalent
K130006BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTSPAISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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