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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) 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. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K182828.

When did Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Surgical Instrument Service and Savings, 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.

K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerK252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterK250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterK250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

View all 23 devices →

Related Devices (Code: NLM)

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.

K201511Reprocessed Endoscopic Trocars and SleevesStryker Sustainability SolutionsK172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc.K172093Reprocessed Covidien TrocarRenovo, Inc.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

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.

↑