Product Code: FZX FDA class 1 21 CFR 878.4800

Guide, Surgical, Instrument

General, Plastic Surgery

The Guide, Surgical, Instrument (product code FZX) is a manual surgical accessory used to direct, position, or align other surgical instruments with precision during general or plastic surgery procedures. It is classified as FDA Class 1, posing minimal risk, subject only to general controls and not requiring premarket notification. The device falls under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

526

Registration Numbers

526

Unique Applicants

Years Active

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Basic Information

Product Code: FZX
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 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K914715	PARALLELING GUIDES	Feb 16, 1994	Substantially Equivalent	Implant Corp. of America
K871413	CIVCO STEPPER	Jul 14, 1987	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.
K871503	BIOPSY NEEDLE GUIDE KIT, STERILE	Jul 10, 1987	Substantially Equivalent	Amedic USA
K862564	A.C.L. GUIDE KIT	Aug 18, 1986	Substantially Equivalent	Aspen Laboratories, Inc.
K854262	MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY	Dec 24, 1985	Substantially Equivalent	Meadox Surgimed, Inc.
K852402	NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER	Jul 11, 1985	Substantially Equivalent	North American Instrument Corp.
K842698	BRITISH SPINAL FUSION SET	Sep 12, 1984	Substantially Equivalent	Downs Surgical , Ltd.
K841618	THREADING TUBE	Aug 27, 1984	Substantially Equivalent	Plastafil, Inc.
K841619	DRILL GUIDE	Jul 11, 1984	Substantially Equivalent	Plastafil, Inc.
K841297	TECHMEDICA DRILL GUIDE	Apr 25, 1984	Substantially Equivalent	Techmedica, Inc.
K840835	STRAITH DRAIN INSERTER	Apr 23, 1984	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K834350	ACUFEX DREZ COMMUNICATING DRILL GUIDE	Mar 19, 1984	Substantially Equivalent	Acufex Microsurgical, Inc.
K830720	GRAF MENISCAL SUTURE SET	Jun 16, 1983	Substantially Equivalent	Acufex Microsurgical, Inc.
K821618	DISPOSABLE NEEDLE HOLDERS	Jun 21, 1982	Substantially Equivalent	Medcare Products
K810888	BOUNDARY TUBING HOLDERS	Apr 23, 1981	Substantially Equivalent	The Buckeye Cellulose Corp.
K810788	SURGICAL TUBE HOLDER	Apr 17, 1981	Substantially Equivalent	The Urology Group
K802093	GABBAY-FRATER SUTURE GUIDE	Sep 26, 1980	Substantially Equivalent	Howmedica Corp.
K792468	FEEDING TUBE PLACEMENT STYLET	Dec 27, 1979	Substantially Equivalent	Biosearch Medical Products, Inc.
K790872	ENTERIC TUBE GUIDE	May 23, 1979	Substantially Equivalent	Biosearch Medical Products, Inc.