KHJ · Class II · 21 CFR 874.3620

FDA Product Code KHJ: Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)

Leading manufacturers include Xomed, Inc., Exmoor Plastics , Ltd. and Cook Biotech Incorporated.

33
Total
33
Cleared
128d
Avg days
1991
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) Devices (Product Code KHJ)

33 devices
1–24 of 33
Cleared May 24, 2024
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6)
K232646
Cook Biotech Incorporated
Ear, Nose, Throat · 268d
Cleared Dec 09, 2008
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
K080022
Vascular Solutions, Inc.
Ear, Nose, Throat · 341d
Cleared Jun 03, 2000
MEROGEL OTOLOGIC PACK
K001148
Xomed, Inc.
Ear, Nose, Throat · 54d
Cleared Nov 03, 1998
EPIFILM OTOLOGIC LAMINA
K982870
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Sep 18, 1998
XOMED SILICONE PRE-FORM BLOCKS
K982294
Xomed, Inc.
Ear, Nose, Throat · 80d
Cleared Jul 16, 1998
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
K972700
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 393d
Cleared Mar 04, 1998
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
K974311
Gyrus Ent LLC
Ear, Nose, Throat · 107d
Cleared May 02, 1997
XOMED SILICONE BLOCK/STRIP
K970910
Xomed, Inc.
Ear, Nose, Throat · 51d
Cleared Jan 24, 1997
KARTUSH TM PATCHER
K964484
Xomed, Inc.
Ear, Nose, Throat · 78d
Cleared Nov 19, 1991
EXMOOR SILICONE RUBBER SHEET
K911503
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 230d

About Product Code KHJ - Regulatory Context

510(k) Submission Activity

33 total 510(k) submissions under product code KHJ since 1991, with 33 receiving FDA clearance (average review time: 128 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.