510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012532Substantially Equivalent

Sepragel Sinus

Genzyme Corporation, Ridgefield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012532 is the FDA 510(k) clearance record for SEPRAGEL SINUS, a class I device, cleared for Genzyme Corp. on under FDA product code LYA (Splint, Intranasal Septal). FDA records list 33 510(k) clearances for Genzyme Corp., from to . As of , FDA records show no recalls naming K012532.

Clearance record

Decision date
Received
(85 days to decision)
Product code
LYA Splint, Intranasal Septal
Regulation
21 CFR 874.4780
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Genzyme Corp. 1125 Pleasant View Terrance, Ridgefield NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LYA

Trailing 12 months

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

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