510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853588Substantially Equivalent

Fibrelight Nasal Specula

Downs Surgical, Ltd., Wilmington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853588 is the FDA 510(k) clearance record for FIBRELIGHT NASAL SPECULA, a class I device, cleared for Downs Surgical , Ltd. on under FDA product code EPY (Speculum, Ent). FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from to . As of , FDA records show no recalls naming K853588.

Clearance record

Decision date
Received
(113 days to decision)
Product code
EPY Speculum, Ent
Regulation
21 CFR 878.1800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Downs Surgical , Ltd. 42 Industrial Way, Wilmington MA
Third party review
No

Clearances, product code EPY

Trailing 12 months

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

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