Product Code: KDC FDA class 1 21 CFR 878.4800

Instrument, Surgical, Disposable

General, Plastic Surgery

A disposable surgical instrument is a single-use instrument intended for use during surgical procedures and then discarded, encompassing a wide variety of cutting, grasping, retracting, or dissecting tools across general and plastic surgery applications. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls and not requiring premarket notification. Product code KDC 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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510(k)s

FEI Numbers

231

Registration Numbers

231

Unique Applicants

Years Active

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Basic Information

Product Code: KDC
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 67 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K943229	DISPOSABLE SURGICAL SCISSORS AND FORCEPS	Aug 19, 1994	Substantially Equivalent	Y.M.K. International Co., Ltd.
K936226	SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET	Mar 07, 1994	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K920153	THERMUFF BAG	Jul 01, 1992	Substantially Equivalent	Techstyles
K920263	MANUAL SURGICAL INSTRUMENTS	May 06, 1992	Substantially Equivalent	Phoenix Instruments Div.
K915064	DISPOSABLE CAUTERY ABRASIVE PAD	Mar 11, 1992	Substantially Equivalent	American Medical Mfg., Inc.
K914960	INSTRUMENT ORGANIZER	Feb 28, 1992	Substantially Equivalent	O.R. Concepts, Inc.
K912834	SHUR-GRIP	Jul 26, 1991	Substantially Equivalent	Inman Medical Corp.
K910079	DISPOSABLE INTRODUCER SHEATH	Feb 27, 1991	Substantially Equivalent	Applied Vascular Devices, Inc.
K905240	VESSELOOPS	Feb 06, 1991	Substantially Equivalent	Sparta Surgical Corp.
K903649	BRADLEY TENACULUM HOLDER	Nov 02, 1990	Substantially Equivalent	Marlo Surgical Technology
K900566	RICHARD-ALLAN VESSEL LOOPS	May 03, 1990	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K896676	KEY VASCULAR LOOPS	Feb 27, 1990	Substantially Equivalent	Key Surgical, Inc.
K854901	PACIFIC GRASPER	May 02, 1986	Substantially Equivalent	Euro-Med Intl.
K854898	ATLANTIC GRASPER	May 02, 1986	Substantially Equivalent	Euro-Med Intl.
K854897	MAX-I-GRASP	May 02, 1986	Substantially Equivalent	Euro-Med Intl.
K854896	HOOK SCISSOR	May 02, 1986	Substantially Equivalent	Euro-Med Intl.
K854895	BASKET FORCEP	May 02, 1986	Substantially Equivalent	Euro-Med Intl.
K854894	SPOON	May 02, 1986	Substantially Equivalent	Euro-Med Intl.
K854890	HOOK PROBE	May 02, 1986	Substantially Equivalent	Euro-Med Intl.
K853597	INSTRUMENT MAKAR DISPOSALBE LOOP	Sep 23, 1985	Substantially Equivalent	Instrument Makar, Inc.
K832441	SUTURE-AID BOOTIES	Mar 05, 1984	Substantially Equivalent	Omega-Med Intl., Inc.
K833355	SDC VASCULAR TIES	Jan 27, 1984	Substantially Equivalent	Science Development Corp.
K831118	PMT-OPTICA LINE	Jan 25, 1984	Substantially Equivalent	Pmt, Inc.
K832680	MICRO-EDGE DISPOSABLE BLADES	Oct 14, 1983	Substantially Equivalent	Micromedics, Inc.
K830800	C-LOOPS	Oct 04, 1983	Substantially Equivalent	Concept, Inc.
K831842	DRAVON T CLAMP	Sep 26, 1983	Substantially Equivalent	Dravon Medical, Inc.
K831915	SAFETY PINS & RUBBER BANDS	Sep 12, 1983	Substantially Equivalent	Ormed Mfg., Inc.
K831911	DISPOSABLE FLOOR INSTRUMENTS	Sep 12, 1983	Substantially Equivalent	Ormed Mfg., Inc.
K831665	DISPOSABLE NEEDLE HOLDER	Sep 12, 1983	Substantially Equivalent	Medcare Products
K831664	PLASTIC THUMB FORCEPS	Sep 12, 1983	Substantially Equivalent	Medcare Products
K831661	DISPOSABLE SCISSORS	Aug 25, 1983	Substantially Equivalent	Medcare Products
K831798	DISPOSABLE SCALPELS	Jul 19, 1983	Substantially Equivalent	I M, Inc.
K831662	DISPOSABLE HEMOSTAT (STRAIGHT&CURVED	Jul 19, 1983	Substantially Equivalent	Medcare Products
K830248	DEVO'N LOOPS	Mar 08, 1983	Substantially Equivalent	Devon Industries, Inc.
K830326	NEGATIVE PRESSURE ARTERIAL BLOOD LINE	Feb 28, 1983	Substantially Equivalent	Erika, Inc.
K822065	KAM SUCKER	Aug 16, 1982	Substantially Equivalent	The Anspach Effort, Inc.
K821166	KOLOR KODE TM	May 13, 1982	Substantially Equivalent	Devon Industries, Inc.
K820638	PEDIATRIC SUCKER	Apr 09, 1982	Substantially Equivalent	3M Health Care, Sarns
K820161	AXIOM LIG-A-BOOTS	Mar 15, 1982	Substantially Equivalent	Axiom Medical, Inc.
K820158	OLSEN #770 DISPOSABLE HOLSTER	Feb 05, 1982	Substantially Equivalent	Olsen Electro-Surgical Instruments, Inc.
K811824	CAUTERY CADDY PAD	Jul 20, 1981	Substantially Equivalent	Instranetics, Inc.
K811823	SHARPS CADDY FB	Jul 20, 1981	Substantially Equivalent	Instranetics, Inc.
K811822	TIP-VU	Jul 20, 1981	Substantially Equivalent	Instranetics, Inc.
K811712	TIP WIPE	Jul 20, 1981	Substantially Equivalent	Devon Industries, Inc.
K811303	ALTRACLUDE	Jun 16, 1981	Substantially Equivalent	R&H Medical, Inc.
K811280	FLEX-TEMPLATE	Jun 02, 1981	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K811191	DAVIS & GECK NEEDLE/SHARPS COUNTER	May 27, 1981	Substantially Equivalent	Davis & Geck, Inc.
K811120	SURGICAL STAPLE REMOVER	May 05, 1981	Substantially Equivalent	Acme United Corp.
K810883	OMED SILICONE INSTRUMENT COVERS	Apr 23, 1981	Substantially Equivalent	Omega-Med Intl., Inc.
K810785	SKIN STAPLE REMOVER	Apr 10, 1981	Substantially Equivalent	Rowley Mfg. Co.
K810080	VASCULAR TIE (VAS-TIE)	Apr 02, 1981	Substantially Equivalent	Sil-Med Corp.
K810269	OMED FABRIC INSTRUMENT COVERS	Feb 26, 1981	Substantially Equivalent	Omega-Med Intl., Inc.
K810260	OMED SILICONE LOOPS	Feb 26, 1981	Substantially Equivalent	Omega-Med Intl., Inc.
K802485	SEARLE VASCULAR LOOPS	Feb 12, 1981	Substantially Equivalent	G.D. Searle and Co.
K810112	SWR DISPOSABLE PREP RAZOR	Feb 04, 1981	Substantially Equivalent	G.D. Searle and Co.
K803156	SURGITEK MEDI-LOOPS	Jan 15, 1981	Substantially Equivalent	Medical Engineering Corp.
K802895	COBE CENTRY 2 VARIABLE CONCENTRATE-18-	Dec 22, 1980	Substantially Equivalent	Cobe Laboratories, Inc.
K802865	SAFE T COUNT	Dec 18, 1980	Substantially Equivalent	Instranetics, Inc.
K802866	SHARPS CADDY MAGNETIC & SHARPS CADDY FOA	Nov 17, 1980	Substantially Equivalent	Instranetics, Inc.
K801908	SI-14	Nov 12, 1980	Substantially Equivalent	Kmi Medical, Inc.
K800015	AXIOM VESSEL LOOPS	Mar 25, 1980	Substantially Equivalent	Axiom Medical, Inc.
K791434	SPONGE COUNTER BAGS	Oct 09, 1979	Substantially Equivalent	Medicare Industries, Inc.
K780880	Y-TYPE BLOOD SET	Jun 30, 1978	Substantially Equivalent	Abbott Laboratories
K780399	INSTRUMENT CLEANING BRUSH	Mar 17, 1978	Substantially Equivalent	Ransom and Randolph
K771702	VESSEL-STABILIZER	Dec 13, 1977	Substantially Equivalent	Med General
K770794	SUTURE REMOVAL SET, STERILE	May 06, 1977	Substantially Equivalent	Lukens Corp.
K760362	LANCET, BLOOD, STERILE STAINLESS STEEL	Sep 13, 1976	Substantially Equivalent	Aeroceuticals