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
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K043035Substantially Equivalent

Sepragel ENT Bioresorbable Packing/stent

Genzyme Corporation, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043035 is the FDA 510(k) clearance record for SEPRAGEL ENT BIORESORBABLE PACKING/STENT, a class II device, cleared for Genzyme Corporation on under FDA product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)). FDA records list 33 510(k) clearances for Genzyme Corporation, from to . As of , FDA records show no recalls naming K043035.

Clearance record

Decision date
Received
(250 days to decision)
Product code
KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Genzyme Corporation 55 Cambridge Pkwy., Cambridge MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHJ

Trailing 12 months
1 clearance under product code KHJ in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KHJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260