Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2027804

FEI Number

1000125732

Entity Name

HK SURGICAL, INC.

City/State/Country

SAN CLEMENTE, CA, US

Establishment Address

1271 PUERTA DEL SOL, SAN CLEMENTE, CA 92673, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

HK SURGICAL, INC. (Owner Number: 9000274)

Owner / Operator Contact Address

1271 PUERTA DEL SOL, --, San Clemente, CA 92673, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Klein Touch Pump HK CV Single Spike Infiltration Tubing Double Spike Infiltration Tubing HK 2X Infiltration Tubing Single Spike Infiltration Tubing Klein Tumescent Infiltration Pump KTIP HK Klein TDD Pump HK ASPIRATOR HK Biopsy Vial Holder Klein Infiltration Pump KIP-II KIP-II+ Monty Cannulas Infiltration Cannulas Capistrano Cannulas Aspiration Cannulas Single Use Infiltration Cannulas Single Use Monty Cannulas IV POLE KIP IV POLE BRACKET KLEIN CART HK SUPER ABSORBANT PADS HK Klein Tumescent Delivery (TD) Syringe Tubing-HK-2TDST HK Klein Tumescent Delivery (TD) Syringe Tubing-HK-1TDST THIGH-A-SIDE MIDINE EXAM PANTIES Aspiration Tubing Fine Touch Tubing HEAVY ASPIRATION TUBING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2014-02-04
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2005-07-18
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2022-03-22
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2008-02-11
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-07-18
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2005-07-18
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2005-07-18
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-02-11
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	1996-09-19
FME	Gown, Examination	General Hospital	Class 1	880.6265	1996-09-19
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2006-09-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HK SURGICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012	B Braun Medical, Inc	2	Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

Similar Registrations

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3012337868	InfuSystem Inc.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027804. Last updated year: 2026. Please use registration number 2027804 when referencing this establishment in official correspondence.