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

FDA 510(k)

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

K-Number: K182828 · 2019-04-15

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2019-04-15
Product CodeNLM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is a medical device manufactured by Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2019-04-15 under approval number K182828. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is a medical device that received FDA 510(k) clearance on 2019-04-15. It is manufactured by Surgical Instrument Service and Savings, Inc.. The 510(k) number is K182828.

When was Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer approved by the FDA?

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer received FDA 510(k) clearance on 2019-04-15, under approval number K182828.

What company makes Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is manufactured by Surgical Instrument Service and Savings, Inc..

What is the FDA product code for Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

The FDA product code for Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is NLM.

Related Clinical Trials

NCT07577232 Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess RECRUITING NCT07554235 Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension NOT_YET_RECRUITING NCT06281249 Neuraxial Ultrasound Device Study NOT_YET_RECRUITING NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED NCT06829667 Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability COMPLETED

Other Devices by Surgical Instrument Service and Savings, Inc.

K163028Medline ReNewal Reprocessed Stryker External Fixation Devices K160333Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider K160740Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology K171911Medline ReNewal Reprocessed Synthes External Fixation Systems K172608Medline ReNewal Reprocessed Stryker SERF AS Energy Probes K161358Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds

View all 23 devices →

Related Devices (Code: NLM)

K160740Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW TechnologySurgical Instrument Service and Savings, Inc. K153258Medline ReNewal Reprocessed Versaport V2 Bladeless Optical TrocarsSurgical Instrument Service and Savings (Dba Medline Renewal K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc. K172093Reprocessed Covidien TrocarRenovo, Inc. K201511Reprocessed Endoscopic Trocars and SleevesStryker Sustainability Solutions

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.

↑