Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA

K-Number: K113494 · 2012-04-19

ApplicantNobles Medical Technologies Ii, Inc.
Decision Date2012-04-19
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA is the device name listed in this FDA 510(k) record. The listed applicant is Nobles Medical Technologies Ii, Inc.. It received FDA 510(k) clearance on 2012-04-19 under 510(k) number K113494. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA?

NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA is a medical device that received FDA 510(k) clearance on 2012-04-19. The listed applicant is Nobles Medical Technologies Ii, Inc.. The 510(k) number is K113494.

When did NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA receive FDA 510(k) clearance?

NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA received FDA 510(k) clearance on 2012-04-19, under 510(k) number K113494.

Who is the listed applicant for NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA?

The FDA 510(k) record lists Nobles Medical Technologies Ii, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA?

The FDA product code for NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA is GAW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nobles Medical Technologies Ii, Inc. 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.

K162617NobleStitch ELK113763SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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.

↑