HK Surgical Inc
San Clemente, CA, US
HK SURGICAL, INC. appears in FDA device records in San Clemente, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for HK Surgical Inc between 2003 and 2020. The busiest year on record is 2003, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2013 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193664 | SubQKath Catheter and Needle Set | BSO | Substantially Equivalent | |
| K123822 | KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET | FRN | Substantially Equivalent | |
| K032802 | HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III | QPB | Substantially Equivalent | |
| K031432 | KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II | FRN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2027804 | 1000125732 | HK SURGICAL, INC. | 1271 PUERTA DEL SOL, SAN CLEMENTE, CA 92673 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- KMOBinder, Elastic
- GEACannula, Surgical, General & Plastic Surgery
- BSOCatheter, Conduction, Anesthetic
- FRLFiber, Medical, Absorbent
- FMEGown, Examination
- FRNPump, Infusion
- FYHSplint, Extremity, Noninflatable, External, Sterile
- FOXStand, Infusion
- KYZSyringe, Irrigating (Non Dental)
- QPBSystem, Suction, Lipoplasty For Removal
- FCHTray, Biopsy, Without Biopsy Instruments
- GAZTubing, Noninvasive
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0900-05 | Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15. | Risk of hubs becoming disconnected from the cannula. | Terminated | ||
| Z-0899-05 | Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23; HK16F5; HK16F8 | Risk of hubs becoming disconnected from the cannula. | Terminated | ||
| Z-0898-05 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain