Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1

Q: What is the product code of K013243?

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.

FDA 510(k) K013243 · Bioform, Inc.

Substantially Equivalent

510(k) numberK013243

Submission

Device name: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1
Applicant: Bioform, Inc.
Franksville, WI, US
Received: September 28, 2001
Decision date: January 9, 2002
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)	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
K122561	Adaptain Fastwrap, Envelock, GraftainKHJ · Traditional	Ceremed , Inc.	11/27/2012SE
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

510(k)	Device	Decision
K033398	Laryngeal Augmentation ImplantMIX · Traditional	12/12/2003SE
K030682	Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3LYC · Traditional	06/27/2003SE
K012955	Coaptite Tissue Marker and Coaptite FN Tissue MarkerNEU · Traditional	10/22/2001SE

Questions and answers

When was Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 cleared by the FDA?

Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 (K013243) received a 510(k) decision of Substantially Equivalent on January 9, 2002, 103 days after the submission was received.

What is the product code of K013243?

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.