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510(k) K172093

Reprocessed Covidien Trocar by Renovo, Inc. — Product Code NLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2017
Date Received
July 11, 2017
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 Renovo, Inc.

  • K173740 — Reprocessed DePuy Mitek Ablation Wand (March 19, 2018)
  • K173741 — Reprocessed ArthoCare Ablation Wand (March 5, 2018)
  • K172647 — Reprocessed ArthroCare ENT Coblator (February 21, 2018)
  • K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Slee (October 6, 2017)
  • K172092 — Reprocessed Shavers/Burs (October 4, 2017)

Other clearances for product code NLM

  • K201511 — Reprocessed Endoscopic Trocars and Sleeves (July 31, 2020)
  • K182828 — Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer (April 15, 2019)
  • K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Slee (October 6, 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)