Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2028661

FEI Number

3005765014

Entity Name

SURGISTAR, INC.

City/State/Country

VISTA, CA, US

Establishment Address

2310 la Mirada Dr, VISTA, CA 92081, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SURGISTAR, INC. (Owner Number: 9005898)

Owner / Operator Contact Address

2310 LA MIRADA DR., --, Vista, CA 92081, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K961524

PMA Number

N/A

All Registered Proprietary Names

Scalpel Trephine Scalpel Ophthalmic Cannula Knife Cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2008-04-22
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-01-18
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2017-01-31
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-05-29
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-07-28
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-04-22
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-04-22
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2008-04-22
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-04-22

Official Correspondent

Don Duong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SURGISTAR, 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
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

Registration Number	Establishment Name	Location
1052728	INVOTEC INTERNATIONAL, INC.	Jacksonville, FL, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
3005675811	QSUM BIOPSY DISPOSABLES LLC	Pequot Lakes, MN, US
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3004050971	VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD.	Dong Guan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2028661. Last updated year: 2026. Please use registration number 2028661 when referencing this establishment in official correspondence.