Cleared Traditional

K182828 - Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer

K182828 is an FDA 510(k) clearance for Medline ReNewal Reprocessed Carter-Thom..., manufactured by Surgical Instrument Service and Savings, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NLM cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K182828 · Surgical Instrument Service and Savings, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
192d
Days
Class 2
Risk

K182828 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer. Classified as Laparoscope, General & Plastic Surgery, Reprocessed (product code NLM), Class II - Special Controls.

Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on April 15, 2019 after a review of 192 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Instrument Service and Savings, Inc. devices

FDA 510(k) Submission Details - K182828

510(k) Number K182828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2018
Decision Date April 15, 2019
Days to Decision 192 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 115d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLM Device Classification - Class 2, Special Controls

Product Code NLM Laparoscope, General & Plastic Surgery, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. This Device Is Indicated For Reuse/reprocessing. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NLM Laparoscope, General & Plastic Surgery, Reprocessed

All 20
Devices cleared under the same product code (NLM) and FDA review panel - the closest regulatory comparables to K182828.
Reprocessed Endoscopic Trocars and Sleeves
K201511 · Stryker Sustainability Solutions · Jul 2020
Reprocessed Ethicon Bladeless Trocars
K172097 · Renovo, Inc. · Oct 2017
Reprocessed Covidien Trocar
K172093 · Renovo, Inc. · Oct 2017
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
K160740 · Surgical Instrument Service and Savings, Inc. · May 2016
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
K153258 · Surgical Instrument Service and Savings (Dba Medline Renewal · Apr 2016
REPROCESSED CLOSURE SYSTEM
K133414 · Sterilmed, Inc. · Jan 2014