510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013133Substantially Equivalent

Nordix Inc Rechargeable Battery Part Number 2116

Nordix, Inc., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013133 is the FDA 510(k) clearance record for NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116, a class I device, cleared for Nordix, Inc. on under FDA product code MOQ (Battery, Replacement, Rechargeable). FDA records list one 510(k) clearance for Nordix, Inc. As of , FDA records show no recalls naming K013133.

Clearance record

Decision date
Received
(55 days to decision)
Product code
MOQ Battery, Replacement, Rechargeable
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Nordix, Inc. 6831 N. 21st Ave., Phoenix AZ
510(k) summary
Statement
Third party review
No

Clearances, product code MOQ

Trailing 12 months

FDA records hold no clearances under product code MOQ in the trailing twelve months.

FDA records show no clearances under product code MOQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MOQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260