FDA-Device2013-05-29Class II

Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

Progressive Medical Inc
Hazard

Product coatings require 510K approval.

Sold states
Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
Affected count
173 boxes with 6 units each.
Manufactured in
997 Horan Dr, N/A, Fenton, MO, United States
Products
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1350-2013

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