Data / Medical devices / United States / HK Surgical, Inc.
HK Surgical, Inc.: FDA-registered device maker in San Clemente, CA, United States, 3 510(k) clearances
HK Surgical, Inc. is registered with the FDA (registration 2027804) in San Clemente, CA, United States. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 27, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2027804
- FEI number
- 1000125732
- Address
- 1271 Puerta Del Sol, San Clemente, CA, United States, 92673
- Owner or operator
- HK SURGICAL, INC. (9000274)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- September 19, 1996
- Registered through
- 2026
- Brand names listed
- Aspiration Cannulas, Aspiration Tubing, CVT-10, CVT-10-VS, CVT-20, Capistrano Cannulas, Double Spike Infiltration Tubing, EXAM PANTIES and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Specification developer | accessdata.fda.gov |
| Binder, Elastic | KMO | 1 | Specification developer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Specification developer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Specification developer | accessdata.fda.gov |
| Splint, Extremity, Noninflatable, External, Sterile | FYH | 1 | Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Specification developer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Specification developer | accessdata.fda.gov |
| Tray, Biopsy, Without Biopsy Instruments | FCH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 27, 2013 | K123822 | KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET | FRN | Substantially Equivalent | Hk Surgical, Inc. | accessdata.fda.gov |
| November 19, 2003 | K032802 | HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III | QPB | Substantially Equivalent | Hk Surgical, Inc. | accessdata.fda.gov |
| August 7, 2003 | K031432 | KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II | FRN | Substantially Equivalent | Hk Surgical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 3, 2004 | 31878 | Not yet classified | Terminated | Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6 | Risk of hubs becoming disconnected from the cannula. | accessdata.fda.gov |
Compare with other makers
- All makers of Splint, Extremity, Noninflatable, External, Sterile
- All makers of Gown, Examination
- All makers of Pump, Infusion
- All makers of Tubing, Noninvasive
- All makers of Stand, Infusion
- All makers of Cannula, Surgical, General & Plastic Surgery
Updated September 27, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.