510(k) K043198

VANGUARD REPROCESSED ARTHROSCOPIC WANDS by Vanguard Medical Concepts, Inc. — Product Code NUJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 27, 2005
Date Received: November 18, 2004
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 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)
K043253 — VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS (April 8, 2005)
K043594 — VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES (March 31, 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)

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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)