Data / Medical devices / United States / Kollsut International Inc
Kollsut International Inc: FDA-registered device maker in North Miami Beach, FL, United States, 13 510(k) clearances
Kollsut International Inc is registered with the FDA (registration 3005953126) in North Miami Beach, FL, United States. It lists 11 device types. The FDA files 13 510(k) clearances under its listings, the newest dated October 20, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005953126
- Address
- 1763 NE 162nd St, North Miami Beach, FL, United States, 33162
- Owner or operator
- KOLLSUT INTERNATIONAL INC (9093450)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 17, 2007
- Registered through
- 2027
- Brand names listed
- BIOLIFT, GILZA, KOFLON, KOLITON, MOLYLON, PIDILEN, RADIK, RESTEL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Natural | GAL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic | GAN | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 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 |
|---|---|---|---|---|---|---|
| October 20, 2020 | K201139 | WEGO-PDO Barbed Suture | NEW | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd. | accessdata.fda.gov |
| February 19, 2020 | K193209 | Wego-Stainless Steel | GAQ | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd. | accessdata.fda.gov |
| January 28, 2019 | K183004 | WEGO-PGA RAPID | GAM | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd. | accessdata.fda.gov |
| January 28, 2019 | K183001 | WEGO-PGLA RAPID | GAM | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd. | accessdata.fda.gov |
| July 31, 2017 | K170842 | WEGO-PTFE | NBY | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd. | accessdata.fda.gov |
| November 14, 2014 | K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | GAM | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd. | accessdata.fda.gov |
| January 14, 2014 | K130737 | SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd. | accessdata.fda.gov |
| January 14, 2014 | K130735 | SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | Foosin Medical Supplies Inc., Ltd. | accessdata.fda.gov |
| December 14, 2010 | K100780 | VITAL SUTURES, SUTUREX, CIRUGIA PERUANA | NEW | Substantially Equivalent | Unilene Sac | accessdata.fda.gov |
| June 9, 2008 | K080684 | WG-SURGICAL SUTURES WITH NEEDLE | GAP | Substantially Equivalent | Foosin Medical Supplies, Inc. | accessdata.fda.gov |
| April 30, 2008 | K073614 | WG-SURGICAL SUTURES WITH NEEDLE | NEW | Substantially Equivalent | Foosin Medical Supplies, Inc. | accessdata.fda.gov |
| July 26, 2006 | K060018 | TRULENE MESH | FTL | Substantially Equivalent | Sutures India Pvt., Ltd. | accessdata.fda.gov |
| September 7, 2005 | K042287 | UNIPLAIN & UNICHROM | GAL | Substantially Equivalent | United Medical Industries Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Mesh, Surgical, Polymeric
- All makers of Suture, Surgical, Absorbable, Polydioxanone
- All makers of Suture, Nonabsorbable, Silk
- All makers of Suture, Nonabsorbable, Synthetic, Polypropylene
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
Updated October 20, 2020. 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.