Biodesign ENT Repair Graft

FDA 510(k) K121360 · Cook Biotech Incorprated

Substantially Equivalent

510(k) numberK121360

Submission

Device name
Biodesign ENT Repair Graft
Applicant
Cook Biotech Incorprated
West Lafayette, IN, US
Received
May 7, 2012
Decision date
February 27, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K260266Tympendi™ (810)KHJ · Traditional Grace Medical, Inc.08/18/2026SE
K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…KHJ · Traditional Cook Biotech Incorporated05/24/2024SE
K161000Biodesign Otologic Repair GraftKHJ · Special Cook Biotech Incorporated05/11/2016SE
K150594Biodesign Otologic Repair GraftKHJ · Traditional Cook Biotech Incorprated09/16/2015SE
K132198Adaptain, Adaptain Fastwrap, Envelock, BiowaiKHJ · Traditional Ceremed , Inc.09/12/2013SE
K122561Adaptain Fastwrap, Envelock, GraftainKHJ · Traditional Ceremed , Inc.11/27/2012SE
K120220Adaptain Soluble Implant MaterialKHJ · Traditional Ceremed , Inc.06/06/2012SE
K103047Ceretene Soluble Implant MaterialKHJ · Traditional Ceremed , Inc.01/05/2011SE
K080022Gel-Sponge ENT, Absorbable Gelatin Sponge, UspKHJ · Traditional Vascular Solutions, Inc.12/09/2008SE
K082245Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LvKHJ · Traditional Ceremed , Inc.09/18/2008SE

More from Ceremed , Inc.

510(k)DeviceDecision
K150668Biodesign Enterocutaneous Fistula PlugFTM · Traditional 12/09/2015SE
K142887SIS Inguinal Hernia Repair GraftFTM · Traditional 10/01/2015SE
K150594Biodesign Otologic Repair GraftKHJ · Traditional 09/16/2015SE

Questions and answers

When was Biodesign ENT Repair Graft cleared by the FDA?

Biodesign ENT Repair Graft (K121360) received a 510(k) decision of Substantially Equivalent on February 27, 2013, 296 days after the submission was received.

What is the product code of K121360?

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.