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
K991757Substantially Equivalent

Non-Absorbable Gauze for External Use, Sterile and Non Sterile

Furlong Industries, Grayslake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991757 is the FDA 510(k) clearance record for NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE, cleared for Furlong Industries on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list one 510(k) clearance for Furlong Industries. As of , FDA records show no recalls naming K991757.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Furlong Industries 311 N. Slusser St., Grayslake IL
510(k) summary
Summary
Third party review
No

Clearances, product code EFQ

Trailing 12 months

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

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