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510(k) K172647

Reprocessed ArthroCare ENT Coblator by Renovo, Inc. — Product Code NUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2018
Date Received
September 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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)
  • K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Slee (October 6, 2017)
  • K172093 — Reprocessed Covidien Trocar (October 5, 2017)
  • K172092 — Reprocessed Shavers/Burs (October 4, 2017)

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  • K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (May 13, 2022)
  • K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer (April 7, 2022)
  • K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (October 22, 2019)
  • K182588 — Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider (October 31, 2018)
  • K180499 — Reprocessed LigaSure Maryland Jaw Sealer/Divider (April 23, 2018)
  • K180451 — Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (April 20, 2018)
  • K173214 — NES Reprocessed RF Stylet (RFS) (March 27, 2018)
  • K173740 — Reprocessed DePuy Mitek Ablation Wand (March 19, 2018)