Product Code: KAM FDA class 1 21 CFR 878.4800

Cannula, Sinus

General, Plastic Surgery

A sinus cannula is a hollow tubular instrument used to irrigate, aspirate, or introduce substances into the paranasal sinuses, typically during ENT procedures for treating sinusitis or performing sinus lavage. It is classified as an FDA Class 1 device, subject only to general controls and not requiring premarket clearance due to its low-risk profile. Product code KAM is regulated under 21 CFR 878.4800 in the General, Plastic Surgery medical specialty. No special flags apply to this device.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: KAM
Device Class: FDA class 1
Regulation Number: 878.4800
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K110687	RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)	Oct 07, 2011	Substantially Equivalent	Acclarent, Inc.
K093594	MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER	Mar 03, 2010	Substantially Equivalent	Acclarent, Inc.
K083574	RELIEVA STRATUS MICROFLOW SPACER	Jan 29, 2009	Substantially Equivalent	Acclarent, Inc.
K072891	SINUS SPACER	Mar 19, 2008	Substantially Equivalent	Acclarent, Inc.
K073041	RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER	Mar 11, 2008	Substantially Equivalent	Acclarent, Inc.
K071845	RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A	Sep 28, 2007	Substantially Equivalent	Acclarent, Inc.
K062458	ETHMOID SINUS SPACER	Sep 15, 2006	Substantially Equivalent	Acclarent, Inc.
K060974	RELIENT NAVIGATION DEVICE	May 05, 2006	Substantially Equivalent	Acclarent, Inc.
K050340	MICROMEDICS SPHENOID SINUS STENT	Apr 27, 2005	Substantially Equivalent	Micromedics, Inc.
K994262	FRONTAL SINUS TREPHINATION CANNULA	Feb 08, 2000	Substantially Equivalent	Xomed, Inc.
K973273	XOMED T-STENT, FRONTAL SINUS STENT	Sep 29, 1997	Substantially Equivalent	Xomed, Inc.
K951803	ROSSITER SINUS STENT	May 11, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K951066	RAINS FRONTAL SINUS STENT	Apr 04, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K942495	SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM	Feb 21, 1995	Substantially Equivalent	Atos Medical AB
K922902	SALMAN SINUS BUTTON	May 18, 1993	Substantially Equivalent	Boston Medical Products, Inc.
K922145	SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS	Jan 21, 1993	Substantially Equivalent	Atos Medical AB
K912418	SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE	Dec 20, 1991	Substantially Equivalent	Micromedics, Inc.
K896630	SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM	Jun 06, 1990	Substantially Equivalent	Atos Medical AB
K813474	MAXILL-AIR SINUS VENTILATION TUBE	Jan 12, 1982	Substantially Equivalent	Xomed, Inc.