510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971000Substantially Equivalent

Epistaxis Nasal Pack

Invotec International, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971000 is the FDA 510(k) clearance record for EPISTAXIS NASAL PACK, a class I device, cleared for Invotec International, Inc. on under FDA product code EMX (Balloon, Epistaxis). FDA records list 16 510(k) clearances for Invotec International, Inc., from to . As of , FDA records show no recalls naming K971000.

Clearance record

Decision date
Received
(56 days to decision)
Product code
EMX Balloon, Epistaxis
Regulation
21 CFR 874.4100
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Invotec International, Inc. 11243-1 St. Johns Industrial, Jacksonville FL
510(k) summary
Statement
Third party review
No

Clearances, product code EMX

Trailing 12 months

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

FDA records show no clearances under product code EMX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EMX, 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