HK SURGICAL INC.

Address:1271 PUERTA DEL SOL,SAN CLEMENTE,CA,92673,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cannula, Surgical, General & Plastic Surgery (GEA) (10)

Premarket Exempt

No Yes

Clear

HK Capistrano Microcannula, 9"-14 gauge - 00816989020423 Catalog Number : HK14C23

Device Description : HK Capistrano Microcannula, 9"-14 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Capistrano Microcannula, 2"-16 gauge - 00816989020430 Catalog Number : HK16C5

Device Description : HK Capistrano Microcannula, 2"-16 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Capistrano Microcannula, 3"-16 gauge - 00816989020447 Catalog Number : HK16C8

Device Description : HK Capistrano Microcannula, 3"-16 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Capistrano Microcannula, 4.75"-16 gauge - 00816989020454 Catalog Number : HK16C12

Device Description : HK Capistrano Microcannula, 4.75"-16 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Capistrano Microcannula, 6"-16 gauge - 00816989020461 Catalog Number : HK16C15

Device Description : HK Capistrano Microcannula, 6"-16 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Capistrano Microcannula, 2"-18 gauge - 00816989020478 Catalog Number : HK18C5

Device Description : HK Capistrano Microcannula, 2"-18 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Capistrano Microcannula, 3"-18 gauge - 00816989020485 Catalog Number : HK18C8

Device Description : HK Capistrano Microcannula, 3"-18 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Capistrano Microcannula, 2.5"-20 gauge - 00816989020492 Catalog Number : HK20C6

Device Description : HK Capistrano Microcannula, 2.5"-20 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Finesse Microcannula, 6"-10 gauge - 00816989020508 Catalog Number : HK10F15

Device Description : HK Finesse Microcannula, 6"-10 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Finesse Microcannula, 9"-10 gauge - 00816989020515 Catalog Number : HK10F23

Device Description : HK Finesse Microcannula, 9"-10 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

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