Product Code: FZT FDA class 1 21 CFR 878.4800

Cutter, Surgical

General, Plastic Surgery

The Cutter, Surgical (product code FZT) is a general-purpose manual cutting instrument used in surgical procedures to incise, divide, or trim tissue during general or plastic surgery. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. The device is regulated under 21 CFR 878.4800 within the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

251

Registration Numbers

251

Unique Applicants

Years Active

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Basic Information

Product Code: FZT
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

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 52 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K112400	SMARTSHEARS	Sep 12, 2011	Substantially Equivalent	Nuscience Consulting and Management Group, LLC
K890818	AUTO SUTURE DISPOSABLE SURGICAL TROCAR*	May 04, 1989	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K872990	MICRINS SURGICAL SCISSOR	Aug 17, 1987	Substantially Equivalent	Micrins Surgical, Inc.
K841741	SINGLE HAIR TRANSPLANT GRAFT	Jul 23, 1984	Substantially Equivalent	Paris Products, Inc.
K841247	SPC DISPOSABLE CUTTER	May 02, 1984	Substantially Equivalent	Surgical Products Corp.
K822448	SCISSORS, VARIOUS	Sep 14, 1982	Substantially Equivalent	J. Sklar Mfg. Co., Inc.
K821632	SURGICAL SCISSORS, SET OF 3	Jun 24, 1982	Substantially Equivalent	Fred Sammons, Inc.
K821361	CONPHAR TONSIL SCISSORS	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821355	CONPHAR LITTAUER SCISSORS	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821352	CONPHAR IRIS SCISSORS	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821351	CONPHAR DISSECTING SCISSORS	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821350	CONPHAR WIRE CUTTING SCISSORS	May 27, 1982	Substantially Equivalent	Conphar, Inc.
K821126	LISTER BANDAGE SCISSORS 3 & 1/2	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821125	OPERATING SCISSORS 5 &1/2 SHARP BLUNT&	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821124	SCISSORS 6 & 1/2 SHARP/BLUNT	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821123	LISTER BANDAGE SCISSORS 7 & 1/2	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821122	OPERATING 5 & 1/2 STRAIGH SHARP/BLUNT	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821121	SCISSORS 5 & 1/2STRAIGHT BLUNT/BLUNT	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821120	OPERATING SCISSORS CURVED 4 & 1/2 BLUNT	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821119	OPERATING SCISSORS 4 & 1/2 BLUNT/BLUNT	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821118	BANDAGE SCISSORS 4 & 1/2	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821117	SCISSORS STRAIGHT 5&1/2SHARP	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821116	LISTER BANDAGE SCISSORS 5 & 1/2	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821115	SCISSORS CURVED 4 & 1/2 SHARP	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821114	OPERATING SCISSORS CURVED 6 & 1/2 SHARP	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821113	OPERATING SCISSORS 5&1/2 CURVED SHARP	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821112	CONPHAR SCISSORS 4&1/2 SHARP BLUNT	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K821111	CONPHAR SCISSORS 4&AHALF SHARPSHARP	May 07, 1982	Substantially Equivalent	Conphar, Inc.
K820170	MED-CARE EMERGENCY SHEARS	Feb 05, 1982	Substantially Equivalent	Medcare Products
K801746	SUTURE REMOVAL PAK	Aug 20, 1980	Substantially Equivalent	Devco Medical Industries, Inc.
K800103	SURGICAL STITCH CUTTER	Jan 28, 1980	Substantially Equivalent	Macon & Co., Inc.
K791984	SCISSOR'S #'S 2294,2262,2263	Oct 17, 1979	Substantially Equivalent	Edward Weck, Inc.
K791742	BROOKS GALL BLADDER SCISSORS (SURG)	Oct 04, 1979	Substantially Equivalent	Edward Weck, Inc.
K791741	FLOOR LINE INSTRUMENTS	Oct 04, 1979	Substantially Equivalent	Edward Weck, Inc.
K791734	SURGICAL INSTRUMENTS HEIFETZ DIGITATE	Sep 12, 1979	Substantially Equivalent	Edward Weck, Inc.
K790684	COLOR CODING OF SURGICAL INSTRUMENTS	May 18, 1979	Substantially Equivalent	Sara Dan, Inc.
K790491	ITIMIZED INSTRUMENTS	Apr 04, 1979	Substantially Equivalent	E.M. Adams
K780574	SUTURE CUTTER	Jul 17, 1978	Substantially Equivalent	Laschal Instrument Corp.
K780575	LASCHAL SCISSOR	Apr 18, 1978	Substantially Equivalent	Laschal Instrument Corp.
K780152	FACELIFT SCISSORS	Feb 02, 1978	Substantially Equivalent	Edward Weck, Inc.
K772301	LAPAROSCOPY DRAPE, BOUNDARY	Dec 20, 1977	Substantially Equivalent	Procter & Gamble Mfg. Co.
K771806	THOREK SCISSORS 7 1/4 & 10	Oct 04, 1977	Substantially Equivalent	J. Sklar Mfg. Co., Inc.
K771743	SURG. SCISSORS FOR CUTTING TISSUE	Sep 26, 1977	Substantially Equivalent	Depuy, Inc.
K770544	SCISSORS, BANDAGE, 15,18,20CM., ANGULAR	Apr 15, 1977	Substantially Equivalent	Sea-Pac Trading Corp.
K770543	SCISSORS, SURGICAL, ANGULAR, 14 CM.	Apr 15, 1977	Substantially Equivalent	Sea-Pac Trading Corp.
K770542	SCISSORS, MAYO _TYLE, 14,16,18,20,22 CM.	Apr 15, 1977	Substantially Equivalent	Sea-Pac Trading Corp.
K770541	SCISSORS, SURGICAL, 12.5,14,16 & 18 CM.	Apr 15, 1977	Substantially Equivalent	Sea-Pac Trading Corp.
K770305	CUTTER, P607 BONE	Mar 09, 1977	Substantially Equivalent	Dentronix, Inc.
K770304	CUTTER, P605 GENERAL PURPOSE	Mar 09, 1977	Substantially Equivalent	Dentronix, Inc.
K770303	NIPPER, NAIL, P610 ENGLISH	Mar 09, 1977	Substantially Equivalent	Dentronix, Inc.
K770302	CUTTER, P606 BONE	Mar 09, 1977	Substantially Equivalent	Dentronix, Inc.
K770301	NIPPER, PSO4 TISSUE	Mar 07, 1977	Substantially Equivalent	Dentronix, Inc.