510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853708Substantially Equivalent

Laryngascopes, Forceps, Micro Suction Tube & Refle

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

K853708 is the FDA 510(k) clearance record for LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE, a class I device, cleared for Downs Surgical , Ltd. on under FDA product code KAE (Forceps, Ent). FDA records list 60 510(k) clearances for Downs Surgical , Ltd., from to . As of , FDA records show no recalls naming K853708.

Clearance record

Decision date
Received
(163 days to decision)
Product code
KAE Forceps, Ent
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Downs Surgical , Ltd. 42 Industrial Way, Wilmington MA
Third party review
No

Clearances, product code KAE

Trailing 12 months

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

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