Product Code: MCZ FDA class 1 21 CFR 878.4800

Suture Removal Kit

General, Plastic Surgery

The suture removal kit is a general and plastic surgery convenience kit containing instruments and supplies used to remove sutures from healed wounds; it falls under FDA enforcement discretion per the May 1997 convenience kits interim regulatory guidance. It is classified as FDA Class I under 21 CFR 878.4800 within the General and Plastic Surgery specialty, subject only to general controls. The product code is MCZ and the device is not GMP-exempt. It is not implanted and does not sustain life.

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510(k)s

FEI Numbers

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Basic Information

Product Code: MCZ
Device Class: FDA class 1
Regulation Number: 878.4800
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 7

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K050656	AMSINO SUTURE REMOVAL KIT	May 02, 2005	Substantially Equivalent	Amsino International, Inc.
K964827	PROD. NO. 01-132 - SUTURE REMOVAL KIT	Feb 14, 1997	Substantially Equivalent	Continental Medical Laboratories, Inc.
K963714	GRAND MEDICAL SUTURE REMOVAL KIT	Nov 27, 1996	Substantially Equivalent	Grand Medical Products
K943046	SKIN STAPLE REMOVAL TRAYS	Jul 29, 1994	Unknown	Sterile Concepts, Inc.
K941465	SUTURE REMOVAL KIT	Apr 22, 1994	Substantially Equivalent	Clinical Resources, Inc.
K931597	CARAPACE INCISION AND DRAINAGE TRAYS	Nov 05, 1993	Unknown	Carapace, Inc.
K925015	STERILE SUTURE REMOVAL KIT	Jun 07, 1993	Unknown	Customed, Inc.
K924835	VALU-PAK STERILE SUTURE REMOVAL KIT (AHC-50-549560	Mar 23, 1993	Unknown	American Healthcare Supply Co., Inc.
K924834	PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957)	Mar 23, 1993	Unknown	American Healthcare Supply Co., Inc.
K922339	SUTURE REMOVAL KIT	Dec 11, 1992	Unknown	Transidyne General Corp.
K915827	A.C.S. SUTURE REMOVAL KIT	Dec 08, 1992	Unknown	American Carolina Stamping
K920283	DISPOSABLE SKIN STAPLE REMOVER	May 22, 1992	Substantially Equivalent	Trinity Laboratories, Inc.
K920280	SUTURE REMOVAL KIT, STERILE, DISPOSABLE	May 11, 1992	Unknown	Trinity Laboratories, Inc.
K910361	SUTURE REMOVAL KIT	Mar 27, 1991	Substantially Equivalent	Megadyne Medical Products, Inc.
K812132	STERILE SUTURE REMOVAL KIT	Dec 01, 1981	Substantially Equivalent	E.M. Adams