510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973085Substantially Equivalent

Ultracell Packing with Sleeve

Ultracell Medical Technologies, Inc., North Stonington CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973085 is the FDA 510(k) clearance record for ULTRACELL PACKING WITH SLEEVE, a class I device, cleared for Ultracell Medical Technologies, Inc. on under FDA product code EMX (Balloon, Epistaxis). FDA records list 24 510(k) clearances for Ultracell Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K973085.

Clearance record

Decision date
Received
(92 days to decision)
Product code
EMX Balloon, Epistaxis
Regulation
21 CFR 874.4100
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Ultracell Medical Technologies, Inc. 183 Providence,New London Tnpk, North Stonington CT
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