510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K913030Substantially Equivalent

Max-I-Probe Irrigation System

Smith & Nephew, Inc., Franklin Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913030 is the FDA 510(k) clearance record for MAX-I-PROBE IRRIGATION SYSTEM, a class I device, cleared for Smith & Nephew, Inc. on under FDA product code EFS (Unit, Oral Irrigation). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K913030.

Clearance record

Decision date
Received
(83 days to decision)
Product code
EFS Unit, Oral Irrigation
Regulation
21 CFR 872.6510
Device class
Class I
Review panel
Dental
Applicant
Smith & Nephew, Inc. 9400 King St., Franklin Park IL
510(k) summary
Statement
Third party review
No

Clearances, product code EFS

Trailing 12 months

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

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