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510(k) K043594

VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES by Vanguard Medical Concepts, Inc. — Product Code NLM

K043594 is an FDA 510(k) premarket notification submitted by Vanguard Medical Concepts, Inc. for the device "VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES". The FDA issued a decision of Substantially Equivalent on March 31, 2005. The device falls under product code NLM (Laparoscope, General & Plastic Surgery, Reprocessed), a Class II device regulated under 21 CFR 876.1500. Vanguard Medical Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2005
Date Received
December 29, 2004
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 Vanguard Medical Concepts, Inc.

  • K053051 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (December 22, 2005)
  • K051616 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (September 6, 2005)
  • K051180 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (July 22, 2005)
  • K051043 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (June 6, 2005)
  • K050763 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (June 1, 2005)
  • K043198 — VANGUARD REPROCESSED ARTHROSCOPIC WANDS (May 27, 2005)
  • K043253 — VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS (April 8, 2005)
  • K043225 — VANGUARD REPROCESSED ULTRASONIC SCALPEL (March 22, 2005)
  • K043315 — VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL (March 22, 2005)
  • K040751 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (March 10, 2005)

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)

FDA data resources