Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004550973

FEI Number

3004550973

Entity Name

TOOLS FOR SURGERY, LLC

City/State/Country

Stony Brook, NY, US

Establishment Address

1339 Stony Brook Rd, Stony Brook, NY 11790, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tools For Surgery, LLC (Owner Number: 9060703)

Owner / Operator Contact Address

8 Technology Drive, #100, East Setauket, NY 11733, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040109

PMA Number

N/A

All Registered Proprietary Names

ZZIREN® Orogastric Tube BARBELL LOOP OSTOMY DEVICE CIRCULAR STAPLER ANVIL SIZER SET CIRCULAR STAPLER HEAD SIZER SET SIREN SGT COLORECTAL AIR SYRINGE-OP COLORECTAL AIR SYRINGE-LP BARIATRIC AIR SYRINGE WIKI DRAIN WIKI DRAINS SOHN'S DILATORS YOUNG'S STYLE RECTAL DILATORS HEMORRHAGE OCCLUDER PIN HEMORRHAGE OCCLUDER PIN WITH APPLICATOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2025-11-19
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	2018-03-03
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2005-12-28
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-05-20
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2020-04-21
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2016-10-28
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2005-12-28
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2007-12-31

Official Correspondent

Arnold Leiboff

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tools For Surgery, LLC

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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0002-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0005-2021	N/A	2	Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Similar Registrations

Registration Number	Establishment Name	Location
3025772870	ENTERAL ACCESS TECHNOLOGIES, LTD.	Caerwys Flintshire, GB
3015237508	ADVANCED MEDICAL BALLOONS GMBH	Waghaeusel Baden-Wurttemberg, DE
3009247326	Jabil Circuit (Singapore) Pte Ltd	Singapore Central Singapore, SG
2528981	LYNX Medical Pennsylvania	ERIE, PA, US
1649518	Sterigenics US LLC	Fort Worth, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004550973. Last updated year: 2026. Please use registration number 3004550973 when referencing this establishment in official correspondence.