Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004447686

FEI Number

3004447686

Entity Name

USGI MEDICAL

City/State/Country

SAN CLEMENTE, CA, US

Establishment Address

1140 CALLE CORDILLERA, SAN CLEMENTE, CA 92673, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

USGI MEDICAL (Owner Number: 9060300)

Owner / Operator Contact Address

1140 CALLE CORDILLERA, --, San Clemente, CA 92673, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K061268

PMA Number

N/A

All Registered Proprietary Names

g-Cath Tissue Anchor G-LIX TISSUE GRASPER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2010-12-10
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2010-12-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2010-12-10
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2006-12-22

Official Correspondent

Tom Palmer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

USGI MEDICAL

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
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K936071	Smith & Nephew Dyonics, Inc.	SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE	1994-08-19
K953574	American Hydro-Surgical Instruments, Inc.	NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER	1995-09-29
K131563	Opus Ksd, Inc.	SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM	2014-04-09
K131705	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	2013-07-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0001-2021	N/A	2	Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004447686. Last updated year: 2026. Please use registration number 3004447686 when referencing this establishment in official correspondence.