KHJ — Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) Class II
FDA product code KHJ covers "Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)", a Class II medical device regulated under 21 CFR 874.3620. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KHJ
- Device Class
- Class II
- Regulation Number
- 874.3620
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232646 | cook biotech incorporated | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Bu | May 24, 2024 |
| K161000 | cook biotech incorporated | Biodesign Otologic Repair Graft | May 11, 2016 |
| K150594 | cook biotech incorprated | Biodesign Otologic Repair Graft | September 16, 2015 |
| K132198 | ceremed | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI | September 12, 2013 |
| K121360 | cook biotech incorprated | BIODESIGN ENT REPAIR GRAFT | February 27, 2013 |
| K122561 | ceremed | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN | November 27, 2012 |
| K120220 | ceremed | ADAPTAIN SOLUBLE IMPLANT MATERIAL | June 6, 2012 |
| K103047 | ceremed | CERETENE SOLUBLE IMPLANT MATERIAL | January 5, 2011 |
| K080022 | vascular solutions | GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP | December 9, 2008 |
| K082245 | ceremed | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV | September 18, 2008 |
| K081531 | ceremed | AOC SOLUBLE IMPLANT MATERIAL | July 18, 2008 |
| K070093 | ceremed | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE | January 24, 2007 |
| K062280 | ceremed | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE | December 11, 2006 |
| K060561 | cambridgemed | CLEARADEX GEL | May 30, 2006 |
| K060878 | curamedical | GELITA-SPON ABSORBABLE GELATIN SPONGE, USP | April 13, 2006 |
| K051487 | doctor research group | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE | December 22, 2005 |
| K051911 | curamedical | GELITA-SPON | December 6, 2005 |
| K043035 | genzyme corporation | SEPRAGEL ENT BIORESORBABLE PACKING/STENT | July 11, 2005 |
| K033796 | heinz kurz gmbh medizintechnik | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS | January 30, 2004 |
| K013243 | bioform | COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 | January 9, 2002 |