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510(k) K042594

VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS by Vanguard Medical Concepts, Inc. — Product Code NON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2005
Date Received
September 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Non-Electric, Reprocessed
Device Class
Class I
Regulation Number
876.1075
Review Panel
GU
Submission Type

same as procode FCL except this product is for the reprocessed device. 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)
  • 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)

Other clearances for product code NON

  • K042648 — REPROCESSED COLD BIOPSY FORCEPS (July 20, 2005)
  • K042659 — MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS (February 14, 2005)