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)

NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE

K-Number: K002755 · 2000-12-04

ApplicantT. Korossurgical Instruments Corp.
Decision Date2000-12-04
Product CodeLRN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is T. Korossurgical Instruments Corp.. It received FDA 510(k) clearance on 2000-12-04 under 510(k) number K002755. The device is classified under product code LRN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE?

NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is T. Korossurgical Instruments Corp.. The 510(k) number is K002755.

When did NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE receive FDA 510(k) clearance?

NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE received FDA 510(k) clearance on 2000-12-04, under 510(k) number K002755.

Who is the listed applicant for NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE?

The FDA 510(k) record lists T. Korossurgical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE?

The FDA product code for NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE is LRN.

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 T. Korossurgical Instruments Corp. 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.

K001915GRAFT MARKER RINGK954016VIDEOSCOPE W/IRRIGATION SHEATHK953998DISCETOME TISSUE ASPIRATORK954052ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTESK954014PERCUTANEOUS DISCECTOMY CANNULA SYSTEMK935529CERVICAL SELF-RETAINING RETRACTOR

View all 27 devices →

Related Devices (Code: LRN)

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.

K990355STAINLESS STEEL SOFT SUTURE WIREBregma International Trading Company , Ltd.K971682J-FX CERCLAGE SYSTEMJohnson & Johnson Professionals, Inc.K952783OXBORO-MEDICAL PIN COVERSOxboro Medical Intl., Inc.K942603ORTHOPAEDIC WIRESAcu Med, Inc.K900926TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)Howmedica Corp.K892651SONGER WIRING SYSTEMDanek Medical, Inc.

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.

↑