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510(k) K100080

REPROCESSED TROCARS, MODEL B5LT AND CB5LT by Ascent Healthcare Solutions — Product Code NLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2010
Date Received
January 12, 2010
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 Ascent Healthcare Solutions

  • K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER (November 15, 2011)
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  • K100909 — REPROCESSED COMPRESSION SLEEVES (July 23, 2010)
  • K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (May 28, 2010)
  • K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FC (May 12, 2010)
  • K093702 — REPROCESSED ULTRASONIC COAGULATING SHEARS (March 4, 2010)
  • K092425 — REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 (October 21, 2009)
  • K090323 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (April 1, 2009)
  • K082023 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (September 16, 2008)
  • K081238 — REPROCESSED MASIMO PULSE OXIMETER SENSORS (July 29, 2008)

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)
  • 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)