Data / Medical devices / Israel / Gordian Surgical
Gordian Surgical: FDA-registered device maker in M.P. Misgav Northern, Israel, 2 510(k) clearances
Gordian Surgical is registered with the FDA (registration 3011803381) in M.P. Misgav Northern, Israel. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 16, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011803381
- Address
- 17 Tchelet Street Misgav Business Park, M.P. Misgav Northern, Israel, 2017400
- Owner or operator
- Gordian surgical Ltd (10053542)
- Roles
- Manufacturer
- First device listed
- September 13, 2017
- Registered through
- 2026
- Brand names listed
- TroClose 1200, Troclose1200, Troclose1200 CANNULA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 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 |
|---|---|---|---|---|---|---|
| December 16, 2025 | K253620 | TroClose 1200 | GAM | Substantially Equivalent | Gordian Surgical, Ltd. | accessdata.fda.gov |
| June 15, 2017 | K171494 | TroClose1200, TroClose1200 Cannula | GAM | Substantially Equivalent | Gordian Surgical, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 22, 2020 | 86483 | Class II | Terminated | TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anc | Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device). | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
Updated December 16, 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.