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Sign in to claim this brandHK 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
- —
- Website
- hksurgical.com
- —
- —
- [email protected]
- Phone
- 949-369-0101
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 106885259
Catalogue (154)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ndo Surgical Surgical Overtube | K002018 | FDA 510(k) | Class II | Active |
| SubQKath Catheter and Needle Set | K193664 | FDA 510(k) | Class II | Active |
| Klein Surgical Infiltration Pump, Model Kip-Ii | K031432 | FDA 510(k) | Class II | Active |
| Klein Touch Pump And Disposable Tubing Set | K123822 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 3, 2004 | Z-0898-05 | — | terminated | Risk of hubs becoming disconnected from the cannula. |
| Dec 3, 2004 | Z-0899-05 | — | terminated | Risk of hubs becoming disconnected from the cannula. |
| Dec 3, 2004 | Z-0900-05 | — | terminated | Risk of hubs becoming disconnected from the cannula. |