Ethicon External Fixation Wire

Q: What is the product code of K821178?

The FDA product code is FYI – Appliance, Facial Fracture, External, a Class I (low risk) device regulated under 21 CFR 878.3250.

FDA 510(k) K821178 · ETHICON, Inc.

Substantially Equivalent

510(k) numberK821178

Submission

Device name: Ethicon External Fixation Wire
Applicant: ETHICON, Inc.
Walker, MI, US
Received: April 27, 1982
Decision date: June 11, 1983
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: FYI – Appliance, Facial Fracture, External
Device class: Class I (low risk)
Regulation: 21 CFR 878.3250
Specialty: General, Plastic Surgery

Other 510(k)s with product code FYI

510(k)	Device	Applicant	Decision
K871073	Omega Bivalve Nasal SplintsFYI · Traditional	Omega Silicone, Inc.	05/11/1987SE
K801072	Straith Nasal SplintFYI · Traditional	Surgical Technology Laboratories, Inc.	06/17/1980SE
K792106	Conphar O.R. Head Cover-SterileFYI · Traditional	Conphar, Inc.	11/05/1979SE

More from Conphar, Inc.

510(k)	Device	Decision
K253394	Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional	06/25/2026SE
K252047	STRATAFIX Symmetric PDS Plus Knotless Tissue Control DevicesNEW · Traditional	05/18/2026SE
K253572	STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX…GAW · Traditional	03/27/2026SE
K253852	MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional	02/06/2026SE
K252743	STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL…GAM · Traditional	12/22/2025SE
K243897	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW · Traditional	11/12/2025SE
K221744	STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional	11/15/2022SE
K212380	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureNEW · Traditional	02/22/2022SE
K213512	DERMABOND PRINEO Skin Closure SystemOMD · Special	12/07/2021SE
K201996	Monocryl Plus Antibacterial SutureGAM · Traditional	12/21/2020SE

Questions and answers

When was Ethicon External Fixation Wire cleared by the FDA?

Ethicon External Fixation Wire (K821178) received a 510(k) decision of Substantially Equivalent on June 11, 1983, 410 days after the submission was received.

What is the product code of K821178?

The FDA product code is FYI – Appliance, Facial Fracture, External, a Class I (low risk) device regulated under 21 CFR 878.3250.