Device product
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5" (16.51cm) Length, Product number P0014M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Z-1356-2013
Product summary
- Event
- Event 64931
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 boxes with 12 units each.
- Official record key
device-enforcement:Z-1356-2013
Official wording
Reason: Product coatings require 510K approval.
Code information: Lot number 082712-04
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.