Data / Medical devices / United States / Tools For Surgery, LLC
Tools For Surgery, LLC: FDA-registered device maker in Stony Brook, NY, United States, 3 510(k) clearances
Tools For Surgery, LLC is registered with the FDA (registration 3004550973) in Stony Brook, NY, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004550973
- Address
- 1339 Stony Brook Rd, Stony Brook, NY, United States, 11790
- Owner or operator
- Tools For Surgery, LLC (9060703)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 28, 2005
- Registered through
- 2026
- Brand names listed
- BARBELL LOOP OSTOMY DEVICE, BARIATRIC AIR SYRINGE, CIRCULAR STAPLER ANVIL SIZER SET, CIRCULAR STAPLER HEAD SIZER SET, COLORECTAL AIR SYRINGE-LP, COLORECTAL AIR SYRINGE-OP, HEMORRHAGE OCCLUDER PIN, HEMORRHAGE OCCLUDER PIN WITH APPLICATOR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dilator, Rectal | FFP | 1 | Manufacturer | accessdata.fda.gov |
| Rod, Colostomy | EZP | 2 | Manufacturer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Manufacturer | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 10, 2025 | K242901 | 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) | KNT | Substantially Equivalent | Tools For Surgery, LLC | accessdata.fda.gov |
| May 18, 2022 | K220218 | Siren SGT | KNT | Substantially Equivalent | Tools For Surgery, LLC | accessdata.fda.gov |
| March 25, 2004 | K040109 | HEMORRHAGE OCCLUDER PIN | GDW | Substantially Equivalent | Tools For Surgery, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Rectal
- All makers of Catheter, Irrigation
- All makers of Staple, Implantable
- All makers of Surgical Instruments, G-U, Manual (And Accessories)
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Rod, Colostomy
Updated January 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.