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 Finesse Microcannula, 4"-12 gauge - 00816989020522 Catalog Number : HK12F10

Device Description : HK Finesse Microcannula, 4"-12 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Finesse Microcannula, 6"-12 gauge - 00816989020539 Catalog Number : HK12F15

Device Description : HK Finesse Microcannula, 6"-12 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Finesse Microcannula, 9"-12 gauge - 00816989020546 Catalog Number : HK12F23

Device Description : HK Finesse Microcannula, 9"-12 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Finesse Microcannula, 4"-14 gauge - 00816989020553 Catalog Number : HK14F10

Device Description : HK Finesse Microcannula, 4"-14 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Finesse Microcannula, 6"-14 gauge - 00816989020560 Catalog Number : HK14F15

Device Description : HK Finesse Microcannula, 6"-14 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Finesse Microcannula, 9"-14 gauge - 00816989020577 Catalog Number : HK14F23

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

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Finesse Microcannula, 2"-16 gauge - 00816989020584 Catalog Number : HK16F5

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

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Finesse Microcannula, 3"-16 gauge - 00816989020591 Catalog Number : HK16F8

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

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Single Port Finesse Microcannula, 3.5"-16 gauge - 00816989020607 Catalog Number : HK16FSP9

Device Description : HK Single Port Finesse Microcannula, 3.5"-16 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

HK Single Port Finesse Microcannula, 2.75"-18 gauge - 00816989020614 Catalog Number : HK18FSP7

Device Description : HK Single Port Finesse Microcannula, 2.75"-18 gauge

Device Class : 1

Duns Number: 106885259

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

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