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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K212838

Benchmark Intracranial Access System · Penumbra, Inc. · decided 2022-05-27 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
BenchmarkBMK6F105SIM130-APENUMBRA, INC.DQY00815948025233
BenchmarkBMK6F115-APENUMBRA, INC.DQY00815948025165
BenchmarkBMK6F105MSIM130-APENUMBRA, INC.DQY00815948025257
BenchmarkBMK6F115M-APENUMBRA, INC.DQY00815948025172
BenchmarkBMK6F95BER120-APENUMBRA, INC.DQY00815948025189
BenchmarkBMK6F95MBER120-APENUMBRA, INC.DQY00815948025202
BenchmarkBMK6F95M-APENUMBRA, INC.DQY00815948025134
BenchmarkBMK6F105MBER130-APENUMBRA, INC.DQY00815948025240
BenchmarkBMK6F95MSIM120-APENUMBRA, INC.DQY00815948025219
BenchmarkBMK6F105BER130-APENUMBRA, INC.DQY00815948025226
BenchmarkBMK6F95SIM120-APENUMBRA, INC.DQY00815948025196
BenchmarkBMK6F105-APENUMBRA, INC.DQY00815948025141
BenchmarkBMK6F95-APENUMBRA, INC.DQY00815948025127
BenchmarkBMK6F105M-APENUMBRA, INC.DQY00815948025158