KHJ · Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Ear, Nose, Throat · 21 CFR 874.3620 · Class 2
Overview
| Product Code | KHJ |
|---|---|
| Device Name | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) |
| Regulation | 21 CFR 874.3620 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
Identification
Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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 | May 24, 2024 | SESE |
| K161000 | Biodesign Otologic Repair Graft | Cook Biotech Incorporated | May 11, 2016 | SESE |
| K150594 | Biodesign Otologic Repair Graft | Cook Biotech Incorprated | Sep 16, 2015 | SESE |
| K132198 | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI | Ceremed , Inc. | Sep 12, 2013 | SESE |
| K121360 | BIODESIGN ENT REPAIR GRAFT | Cook Biotech Incorprated | Feb 27, 2013 | SESE |
| K122561 | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN | Ceremed , Inc. | Nov 27, 2012 | SESE |
| K120220 | ADAPTAIN SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | Jun 6, 2012 | SESE |
| K103047 | CERETENE SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | Jan 5, 2011 | SESE |
| K080022 | GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP | Vascular Solutions, Inc. | Dec 9, 2008 | SESE |
| K082245 | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV | Ceremed , Inc. | Sep 18, 2008 | SESE |
| K081531 | AOC SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | Jul 18, 2008 | SESE |
| K070093 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE | Ceremed , Inc. | Jan 24, 2007 | SESE |
| K062280 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE | Ceremed , Inc. | Dec 11, 2006 | SESE |
| K060561 | CLEARADEX GEL | Cambridgemed | May 30, 2006 | SESE |
| K060878 | GELITA-SPON ABSORBABLE GELATIN SPONGE, USP | Curamedical, BV | Apr 13, 2006 | SESE |
| K051487 | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE | Doctor'S Research Group, Inc. | Dec 22, 2005 | SESE |
| K051911 | GELITA-SPON | Curamedical, BV | Dec 6, 2005 | SESE |
| K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT | Genzyme Corporation | Jul 11, 2005 | SESE |
| K033796 | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS | Heinz Kurz GmbH Medizintechnik | Jan 30, 2004 | SESE |
| K013243 | COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 | Bioform, Inc. | Jan 9, 2002 | SESE |
Top Applicants
- Ceremed , Inc. — 8 clearances
- Xomed, Inc. — 5 clearances
- Cook Biotech Incorporated — 2 clearances
- Cook Biotech Incorprated — 2 clearances
- Curamedical, BV — 2 clearances
