Vanguard Reprocessed Non-Electric Biopsy Forceps

FDA 510(k) K042594 · Vanguard Medical Concepts, Inc.

Substantially Equivalent

510(k) numberK042594

Submission

Device name
Vanguard Reprocessed Non-Electric Biopsy Forceps
Applicant
Vanguard Medical Concepts, Inc.
Lakeland, FL, US
Received
September 23, 2004
Decision date
January 25, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NON – Forceps, Biopsy, Non-Electric, Reprocessed
Device class
Class I (low risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

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 510(k)s with product code NON

510(k)DeviceApplicantDecision
K042648Reprocessed Cold Biopsy ForcepsNON · Traditional Sterilmed, Inc.07/20/2005SE
K042659Medisiss Reprocessed Non-Electric Gi Biopsy ForcepsNON · Traditional Medisiss02/14/2005SE

More from Medisiss

510(k)DeviceDecision
K053051Vanguard Reprocessed External Fixation DevicesKTT · Traditional 12/22/2005SE
K051616Vanguard Reprocessed External Fixation DevicesKTT · Traditional 09/06/2005SE
K051180Vanguard Reprocessed External Fixation DevicesKTT · Traditional 07/22/2005SE
K051043Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional 06/06/2005SE
K050763Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional 06/01/2005SE
K043198Vanguard Reprocessed Arthroscopic WandsNUJ · Traditional 05/27/2005SE
K043253Vanguard Reprocessed Dilating Tip and Blunt TrocarsNLM · Traditional 04/08/2005SE
K043594Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar AccessoriesNLM · Traditional 03/31/2005SE
K043315Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelNLQ · Traditional 03/22/2005SE
K043225Vanguard Reprocessed Ultrasonic ScalpelNLQ · Traditional 03/22/2005SE

Questions and answers

When was Vanguard Reprocessed Non-Electric Biopsy Forceps cleared by the FDA?

Vanguard Reprocessed Non-Electric Biopsy Forceps (K042594) received a 510(k) decision of Substantially Equivalent on January 25, 2005, 124 days after the submission was received.

What is the product code of K042594?

The FDA product code is NON – Forceps, Biopsy, Non-Electric, Reprocessed, a Class I (low risk) device regulated under 21 CFR 876.1075.