SUTURE EASE, INC.

FDA Device Registration & Listing · Galt, CA, US · Registration 3009956343

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009956343
FEI Number
3009956343
Entity Name
SUTURE EASE, INC.
City/State/Country
Galt, CA, US
Establishment Address
908 C Street, Suite F-1, Galt, CA 95632, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Suture Ease, Inc (Owner Number: 10042219)
Owner / Operator Contact Address
908 C Street, Suite F-1, Galt, CA 95632, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K172666
PMA Number
N/A

All Registered Proprietary Names

SecurusEP Passer EZ Stitch Securus Fascial Closure System EZ Stitch Reusable Passer CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor CrossBow Reusable Passer LongBow with Adaptor LongBow Fascial Closure System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2012-11-01
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2018-02-28
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2018-02-28

Official Correspondent

Gena Parker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Suture Ease, 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
K082659 Covidien Lp, Formerly Registered AS United States MODIFIED ENDO STICH 2008-09-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009956343. Last updated year: 2026. Please use registration number 3009956343 when referencing this establishment in official correspondence.
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