510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K010708Substantially Equivalent

Applicator Tip/dual Sprayer Kit

Interpore Cross Intl., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010708 is the FDA 510(k) clearance record for APPLICATOR TIP/DUAL SPRAYER KIT, a class II device, cleared for Interpore Cross Intl. on under FDA product code FMF (Syringe, Piston). FDA records list 39 510(k) clearances for Interpore Cross Intl., from to . As of , FDA records show no recalls naming K010708.

Clearance record

Decision date
Received
(52 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Interpore Cross Intl. 181 Technology Dr., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260