Adaptain Fastwrap, Envelock, Graftain
FDA 510(k) K122561 · Ceremed , Inc.
510(k) numberK122561
Submission
- Device name
- Adaptain Fastwrap, Envelock, Graftain
- Applicant
- Ceremed , Inc.
Los Angeles, CA, US - Received
- August 22, 2012
- Decision date
- November 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code KHJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260266 | Tympendi (810)KHJ · Traditional | Grace Medical, Inc. | 08/18/2026SE |
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…KHJ · Traditional | Cook Biotech Incorporated | 05/24/2024SE |
| K161000 | Biodesign Otologic Repair GraftKHJ · Special | Cook Biotech Incorporated | 05/11/2016SE |
| K150594 | Biodesign Otologic Repair GraftKHJ · Traditional | Cook Biotech Incorprated | 09/16/2015SE |
| K132198 | Adaptain, Adaptain Fastwrap, Envelock, BiowaiKHJ · Traditional | Ceremed , Inc. | 09/12/2013SE |
| K121360 | Biodesign ENT Repair GraftKHJ · Traditional | Cook Biotech Incorprated | 02/27/2013SE |
| K120220 | Adaptain Soluble Implant MaterialKHJ · Traditional | Ceremed , Inc. | 06/06/2012SE |
| K103047 | Ceretene Soluble Implant MaterialKHJ · Traditional | Ceremed , Inc. | 01/05/2011SE |
| K080022 | Gel-Sponge ENT, Absorbable Gelatin Sponge, UspKHJ · Traditional | Vascular Solutions, Inc. | 12/09/2008SE |
| K082245 | Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LvKHJ · Traditional | Ceremed , Inc. | 09/18/2008SE |
More from Ceremed , Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161446 | Biopor Porous Polyethylene ImplantsGWO · Traditional | 09/27/2016SE |
| K160988 | Biopor, AOC Porous Polyethylene, CereporKKY · Traditional | 07/14/2016SE |
| K141880 | Biopor Aoc Porous Polyethylene, CereporKKY · Traditional | 04/16/2015SE |
| K132198 | Adaptain, Adaptain Fastwrap, Envelock, BiowaiKHJ · Traditional | 09/12/2013SE |
| K120220 | Adaptain Soluble Implant MaterialKHJ · Traditional | 06/06/2012SE |
| K103047 | Ceretene Soluble Implant MaterialKHJ · Traditional | 01/05/2011SE |
| K102071 | Ostene CT, Aoc CT, Osteotene, CereteneMTJ · Traditional | 10/08/2010SE |
| K091636 | Ostene CT, Aoc CT, Osteotene, CereteneMTJ · Special | 06/22/2009SE |
| K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene &…MTJ · Special | 09/24/2008SE |
| K082245 | Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LvKHJ · Traditional | 09/18/2008SE |
Questions and answers
When was Adaptain Fastwrap, Envelock, Graftain cleared by the FDA?
Adaptain Fastwrap, Envelock, Graftain (K122561) received a 510(k) decision of Substantially Equivalent on November 27, 2012, 97 days after the submission was received.
What is the product code of K122561?
The FDA product code is KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material), a Class II (moderate risk) device regulated under 21 CFR 874.3620.