Gordian Surgical, Ltd.
IsraelFDA applicant, unverified FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Gordian Surgical, Ltd. makes
Gordian Surgical, Ltd. manufactures laparoscopic access cannulation and wound closure sets, including reusable and disposable systems designed for single-incision or multiport procedures. Their portfolio includes the TroClose1200 series, which combines cannula insertion with wound closure functionality to reduce port-site complications. These devices are intended for use in minimally invasive surgeries, such as gynecological, urological, and general abdominal procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and UDI databases. The portfolio is regulated in the United States, where Gordian Surgical, Ltd. is based.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
TroClose 1200 Ref K253620
Regimes: 510(k) Registry: 510(k)TroClose1200, TroClose1200 Cannula Ref K171494
Regimes: 510(k) Registry: 510(k)TroClose1200 Ref K160564
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 600087854
- [email protected]
- Phone
- +1-619-467-3426
FDA recalls
FDA recall records list 1 recall initiated by Gordian Surgical, Ltd., initiated on 2020-09-22. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 22 Sep 2020 Z-0398-2021 Class II Terminated Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
FDA establishments
- Gordian Surgical M.P. Misgav Northern · IL FEI 3011803381
Frequently asked questions
How many devices does Gordian Surgical, Ltd. have in the registry?
The registry currently lists 6 devices for Gordian Surgical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gordian Surgical, Ltd.'s devices?
Among its 6 most recently registered devices, Gordian Surgical, Ltd. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Gordian Surgical, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Gordian Surgical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Gordian Surgical, Ltd.?
FDA recall records list 1 recall initiated by Gordian Surgical, Ltd., the most recent initiated on 22 Sep 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Gordian Surgical, Ltd. in the registry?
The most recently registered devices listed for Gordian Surgical, Ltd. include TroClose1200™ GSTC1200, TroClose1200™ GSTC1200C, TroClose 1200 and TroClose1200, TroClose1200 Cannula.
Which FDA establishments are linked to Gordian Surgical, Ltd.?
1 FDA establishment is linked to Gordian Surgical, Ltd. in the registry; they are listed on the company page.