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FDA 510(k)

TroClose1200

K-Number: K160564 · 2016-11-17

ApplicantGordian Surgical, Ltd.
Decision Date2016-11-17
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TroClose1200 is the device name listed in this FDA 510(k) record. The listed applicant is Gordian Surgical, Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K160564. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TroClose1200?

TroClose1200 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Gordian Surgical, Ltd.. The 510(k) number is K160564.

When did TroClose1200 receive FDA 510(k) clearance?

TroClose1200 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K160564.

Who is the listed applicant for TroClose1200?

The FDA 510(k) record lists Gordian Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TroClose1200?

The FDA product code for TroClose1200 is GAM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07649915GRIP: Gordian Robotic Integrated Port Closure StudyNOT_YET_RECRUITING

Other records listing Gordian Surgical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253620TroClose 1200K171494TroClose1200, TroClose1200 Cannula

Related Devices (Code: GAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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