Home / 510(k) Clearances / K182828

510(k) K182828

Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer by Surgical Instrument Service and Savings, Inc. — Product Code NLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2019
Date Received
October 5, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery, Reprocessed
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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).

Other clearances by Surgical Instrument Service and Savings, Inc.

  • K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (December 19, 2025)
  • K252405 — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerab (November 26, 2025)
  • K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerabl (July 11, 2025)
  • K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound (June 5, 2025)
  • K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for S (March 10, 2025)
  • K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (November 29, 2024)
  • K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter (September 14, 2024)
  • K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Si (September 10, 2024)
  • K240972 — Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (June 7, 2024)
  • K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (April 29, 2024)

Other clearances for product code NLM

  • K201511 — Reprocessed Endoscopic Trocars and Sleeves (July 31, 2020)
  • K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Slee (October 6, 2017)
  • K172093 — Reprocessed Covidien Trocar (October 5, 2017)
  • K160740 — Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology (May 6, 2016)
  • K153258 — Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars (April 5, 2016)
  • K133414 — REPROCESSED CLOSURE SYSTEM (January 22, 2014)
  • K132629 — REPROCESSED DILATING TIP TROCARS (December 31, 2013)
  • K121240 — REPROCESSED ENDOSCOPIC TROCARS (June 11, 2012)
  • K111002 — REPROCESSED ENDOSCOPIC TROCARS (July 18, 2011)
  • K100080 — REPROCESSED TROCARS, MODEL B5LT AND CB5LT (March 19, 2010)