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HK SURGICAL INC.

US

Last updated May 24, 2026

What HK SURGICAL INC. makes

HK Surgical Inc. manufactures reusable and single-use cannulas for liposuction systems, including infiltration and aspiration tools with varying gauges and lengths, as well as irrigation/aspiration tubing sets for surgical procedures. Their product line also includes sterile and non-sterile absorbent wound compression pads and underpads, alongside single-channel bedside infusion pumps designed for controlled fluid delivery.

The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories, and are listed in the FDA’s 510(k) and UDI registries. HK Surgical Inc. is based in the United States, adhering to domestic regulatory requirements for medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
949-369-0101
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
106885259

Catalogue (154)

Page 2 of 4
DeviceModel / ReferenceRegistriesClassStatus
HK Finesse Microcannula, 6"-10 gauge HK10F15
FDA UDI
Class IActive
HK Non-Sterile Super Absorbent Pads Small PD-S
FDA UDI
Class IActive
HK Monty Infiltration Cannula, 8"-14 gauge Full Monty IC14FM20
FDA UDI
Class IActive
HK Monty Infiltration Cannula, 6"-16 gauge Tip Monty IC16TM15
FDA UDI
Class IActive
Klein Touch Pump KTP
FDA UDI
Class IIUnknown
HK Mercedes Cannula 4mm X 25cm Luer Lock HKMER425
FDA UDI
Class IActive
HK Capistrano Microcannula, 6"-14 gauge HK14C15
FDA UDI
Class IActive
HK Sterile Super Absorbent Pads Large SPD-L
FDA UDI
Class IActive
HK CV Single Spike Infiltration Tubing - Vascular Solutions CVT-20VS
FDA UDI
Class IUnknown
HK Tumescent Infiltration Cannula, (10cm) 4"-18 gauge, Single Use, Box of 10 SU-IC18x10
FDA UDI
Class IActive
HK Mercedes Cannula 3mm X 15cm Luer Lock HKMER315
FDA UDI
Class IActive
Heavy Aspiraton Tubing AT375
FDA UDI
Class IIActive
Aspiration Handle-Aluminum Small with Hole 3/4" diameter AHSH
FDA UDI
Class IActive
HK Monty Infiltration Cannula, 6"-16 gauge Full Monty IC16FM15
FDA UDI
Class IActive
Fine Touch Aspiration Tubing ATF-20
FDA UDI
Class IIUnknown
HK Capistrano Microcannula, 6"-10 gauge HK10C15
FDA UDI
Class IActive
Aspiration Tubing AT6-10
FDA UDI
Class IIActive
HK Tumescent Infiltration Cannula, (23cm) 9"-12 gauge, Single Use, Box of 10 SU-IC12x23
FDA UDI
Class IActive
HK Capistrano Microcannula, 4.75"-16 gauge HK16C12
FDA UDI
Class IActive
HK Infiltration Microcannula, 9"-12 gauge IC12x23
FDA UDI
Class IActive
Double Spike Infiltration Tubing ITD-20
FDA UDI
Class IActive
HK Toledo Cannula 4mm x 25cm Luer Lock HKTOL425
FDA UDI
Class IActive
HK Tumescent Infiltration Cannula, (15cm) 6"-16 gauge, Single Use, Box of 10 SU-IC16x15
FDA UDI
Class IActive
HK Tumescent Infiltration Cannula Half Monty, (20cm) 8"-14 gauge, Single Use, Bo SU-IC14HM20
FDA UDI
Class IActive
HK Capistrano Microcannula, 2"-16 gauge HK16C5
FDA UDI
Class IActive
Aspiration Tubing AT6-10
FDA UDI
Class IIUnknown
HK Infiltration Microcannula, 4"-18 gauge IC18x10
FDA UDI
Class IActive
HK Multi Hole Spray Needle 16ga x 20cm Luer Lock HKMHS1620
FDA UDI
Class IActive
HK Capistrano Microcannula, 3"-16 gauge HK16C8
FDA UDI
Class IActive
HK Aspirator Pump 230 V AP-230III
FDA UDI
Class IIUnknown
Single Spike Infiltration Tubing ITS-10
FDA UDI
Class IActive
HK Monty Infiltration Cannula, 6"-18 gauge Tip Monty IC18TM15
FDA UDI
Class IActive
Aluminum Infiltration Handle-Small 3/4" diameter IHSS
FDA UDI
Class IActive
HK HK-2015-MER+215LL (HK-2015 Mercedes Plus Cannula 2mm x 15cm Luer Lock) HKMER+215
FDA UDI
Class IActive
HK Tumescent Infiltration Cannula, (8cm) 3"-18 gauge, Single Use, Box of 10 SU-IC18x8
FDA UDI
Class IActive
HK Multi Hole Spray Needle 18ga x 30cm Luer Lock HKMHS1830
FDA UDI
Class IActive
HK Tumescent Infiltration Cannula, (8cm) 3"-16 gauge, Single Use, Box of 10 SU-IC16x8
FDA UDI
Class IActive
HK Monty Infiltration Cannula, 6"-16 gauge Half Monty IC16HM15
FDA UDI
Class IActive
HK 2X Infiltration Tubing IT2X-10
FDA UDI
Class IUnknown
HK Tumescent Infiltration Cannula Full Monty, (15cm) 6"-18 gauge, single use, bo SU-IC18FM15
FDA UDI
Class IActive
HK Non-Sterile Super Absorbent Pads Rectangle PD-R
FDA UDI
Class IActive
HK Non-Sterile Super Absorbent Pads XL PD-XL
FDA UDI
Class IActive
HK Capistrano Microcannula, 6"-12 gauge HK12C15
FDA UDI
Class IActive
HK Finesse Microcannula, 2"-16 gauge HK16F5
FDA UDI
Class IActive
HK Monty Infiltration Cannula, 8"-14 gauge Half Monty IC14HM20
FDA UDI
Class IActive
HK Connector for Safety Syringe HKCONFSS
FDA UDI
Class IActive
ReShape Infiltration Pump KIP-II-RS
FDA UDI
Class IIUnknown
Single Spike Infiltration Tubing ITS-20
FDA UDI
Class IUnknown
Klein Infiltration Pump II KIP-II
FDA UDI
Class IIUnknown
HK Infiltration Microcannula, 9"-14 gauge IC14x23
FDA UDI
Class IActive

Related Companies

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

HK Surgical Inc. has three recall records, all initiated on December 3, 2004, with each listed as terminated. The sole reason cited across all records involves a risk of hubs becoming disconnected from the cannula.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Dec 3, 2004Z-0898-05—terminated

Risk of hubs becoming disconnected from the cannula.

Dec 3, 2004Z-0899-05—terminated

Risk of hubs becoming disconnected from the cannula.

Dec 3, 2004Z-0900-05—terminated

Risk of hubs becoming disconnected from the cannula.