Product code KHJ
- Device name
- Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.3620
- Review panel
- EN
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | Cook Biotech Incorporated | 2024-05-24 |
| K161000 | Biodesign Otologic Repair Graft | Cook Biotech Incorporated | 2016-05-11 |
| K150594 | Biodesign Otologic Repair Graft | Cook Biotech Incorprated | 2015-09-16 |
| K132198 | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI | Ceremed , Inc. | 2013-09-12 |
| K121360 | BIODESIGN ENT REPAIR GRAFT | Cook Biotech Incorprated | 2013-02-27 |
| K122561 | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN | Ceremed , Inc. | 2012-11-27 |
| K120220 | ADAPTAIN SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2012-06-06 |
| K103047 | CERETENE SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2011-01-05 |
| K080022 | GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP | Vascular Solutions, Inc. | 2008-12-09 |
| K082245 | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV | Ceremed , Inc. | 2008-09-18 |
| K081531 | AOC SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2008-07-18 |
| K070093 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE | Ceremed , Inc. | 2007-01-24 |
| K062280 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE | Ceremed , Inc. | 2006-12-11 |
| K060561 | CLEARADEX GEL | Cambridgemed | 2006-05-30 |
| K060878 | GELITA-SPON ABSORBABLE GELATIN SPONGE, USP | Curamedical, BV | 2006-04-13 |
| K051487 | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE | Doctor'S Research Group, Inc. | 2005-12-22 |
| K051911 | GELITA-SPON | Curamedical, BV | 2005-12-06 |
| K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT | Genzyme Corporation | 2005-07-11 |
| K033796 | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS | Heinz Kurz GmbH Medizintechnik | 2004-01-30 |
| K013243 | COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 | Bioform, Inc. | 2002-01-09 |
| K003855 | HYALOMATRIX CO | Fidia Advanced Biopolymers Srl | 2001-07-03 |
| K002972 | MEROGEL CONTROL GEL ENT SURGICAL DRESSING | Medtronic Xomed | 2000-12-15 |
| K001148 | MEROGEL OTOLOGIC PACK | Xomed, Inc. | 2000-06-03 |
| K991324 | TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) | Heinz Kurz | 1999-05-18 |
| K982870 | EPIFILM OTOLOGIC LAMINA | Xomed, Inc. | 1998-11-03 |
| K982294 | XOMED SILICONE PRE-FORM BLOCKS | Xomed, Inc. | 1998-09-18 |
| K972700 | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) | Exmoor Plastics , Ltd. | 1998-07-16 |
| K974311 | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT | Gyrus Ent LLC | 1998-03-04 |
| K970910 | XOMED SILICONE BLOCK/STRIP | Xomed, Inc. | 1997-05-02 |
| K964484 | KARTUSH TM PATCHER | Xomed, Inc. | 1997-01-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850056665305 | ORCA Foam | Orca Products, LLC | 2026-05-07 |
| 00810235030853 | Prolaryn Plus | MERZ NORTH AMERICA, INC. | 2026-02-24 |
| 00850056665292 | ORCA Foam Powder | Orca Products, LLC | 2025-09-30 |
| 00850056665223 | ORCA Foam | Orca Products, LLC | 2025-04-07 |
| 00850056665247 | ORCA Foam Powder | Orca Products, LLC | 2025-04-07 |
| 00850056665193 | ORCA Foam | Orca Products, LLC | 2025-02-25 |
| 00850056665100 | ORCA Foam Powder | Orca Products, LLC | 2024-12-05 |
| 00850056665124 | ORCA Foam Powder | Orca Products, LLC | 2024-12-05 |
| 00850056665148 | ORCA Foam Powder | Orca Products, LLC | 2024-12-05 |
| 00827002602854 | Biodesign | COOK BIOTECH INCORPORATED | 2024-05-31 |
| 00860008294333 | ORCA Foam | Orca Products, LLC | 2023-09-15 |
| 10860008294347 | ORCA Foam | Orca Products, LLC | 2023-09-15 |
| 00860008294357 | ORCA Foam | Orca Products, LLC | 2023-09-15 |
| 00860008294388 | ORCA Foam | Orca Products, LLC | 2023-09-15 |
| 00850056665001 | ORCA Foam | Orca Products, LLC | 2023-09-15 |
| 00850056665025 | ORCA Foam | Orca Products, LLC | 2023-09-15 |
| 10860003109974 | ORCA Foam | Orca Products, LLC | 2022-02-24 |
| 10860008294309 | ORCA Foam | Orca Products, LLC | 2022-02-24 |
| 10860003109981 | ORCA Foam | Orca Products, LLC | 2022-02-24 |
| 04260293133076 | GELITA-SPON® STANDARD | GELITA MEDICAL GmbH | 2021-07-28 |
| 04260293133083 | GELITA-SPON® STANDARD | GELITA MEDICAL GmbH | 2021-07-27 |
| 04260293133106 | GELITA-SPON® STANDARD | GELITA MEDICAL GmbH | 2021-07-27 |
| 04260293133144 | GELITA-SPON® STANDARD | GELITA MEDICAL GmbH | 2021-07-27 |
| 04260293133069 | GELITA-SPON® STANDARD | GELITA MEDICAL GmbH | 2021-03-21 |
| 00860003109915 | ORCA Foam | Orca Products, LLC | 2020-12-15 |
| 00763000040253 | N/A | MEDTRONIC XOMED, INC. | 2020-06-29 |
| 00763000040246 | N/A | MEDTRONIC XOMED, INC. | 2020-06-29 |
| 00763000040239 | N/A | MEDTRONIC XOMED, INC. | 2020-06-29 |
| 00763000040222 | N/A | MEDTRONIC XOMED, INC. | 2020-06-29 |
| 00763000040215 | N/A | MEDTRONIC XOMED, INC. | 2020-06-29 |