Device product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 6.5" (16.51cm) Length, Product number P0014, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Z-1349-2013
Product summary
- Event
- Event 64931
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 boxes with 12 units each.
- Official record key
device-enforcement:Z-1349-2013
Official wording
Reason: Product coatings require 510K approval.
Code information: Lot number 071212-03
Distribution pattern: 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.
Derived failure modes
-
Unknown
Product coatings require 510K approval.