Medical Device Manufacturer · US , Stony Brook , NY

Tools For Surgery, LLC

4 submissions · 4 cleared · Since 2004

Total

Cleared

Denied

Tools For Surgery, LLC — FDA 510(k) Submissions

Tools For Surgery, LLC has submitted 4 FDA 510(k) premarket notifications since 2004, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tubes, Gastrointestinal (and Accessories), Staple, Implantable, Rod, Colostomy . Use the specialty filter in the sidebar to narrow results.

4 devices

1–4 of 4

ZZIREN? Orogastric Tube; ZZIREN? SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN? SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN? SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN? GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN? GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN? GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

K242901 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology

Jan 2025 109d

Siren SGT

K220218 · KNT Tubes, Gastrointestinal... · Gastroenterology & Urology

May 2022 112d

HEMORRHAGE OCCLUDER PIN

K040109 · GDW Staple, Implantable · General & Plastic Surgery

Mar 2004 65d

EASY LOOP, MODEL EZL-01