Product Code: FTY FDA class 1 21 CFR 878.4800

Tape, Measuring, Rulers And Calipers

General, Plastic Surgery

A surgical measuring tape, ruler, or caliper is a precision measurement instrument used in operative settings to measure anatomical dimensions, wound size, or tissue geometry, assisting in surgical planning and execution. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FTY, regulated under 21 CFR 878.4800, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

398

Registration Numbers

398

Unique Applicants

Years Active

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Basic Information

Product Code: FTY
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 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K160501	Noxilizer Surgical Ruler	May 26, 2016	Substantially Equivalent	Noxilizer, Inc.
K951064	DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC	May 19, 1995	Substantially Equivalent	S-E Sales & Distribution, Inc.
K934930	OLYMPIC AUTO-LENGTH	Dec 29, 1993	Substantially Equivalent	Olympic Medical Corp.
K932112	OLYMPIC INFA-LENGTH	Jul 22, 1993	Substantially Equivalent	Olympic Medical Corp.
K883485	STRYKER PRESSURE MONITOR SYSTEM	Sep 13, 1988	Substantially Equivalent	Stryker Corp.
K880441	PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.	Feb 18, 1988	Substantially Equivalent	Plane Iii, Inc.
K874352	TUMORIMETER	Nov 23, 1987	Substantially Equivalent	Cancer Technologies, Inc.
K873470	TEMPLATE	Sep 08, 1987	Substantially Equivalent	Cox-Uphuff Intl.
K872319	LN 100 BREAST MARKER	Aug 11, 1987	Substantially Equivalent	Instrumentation Industries, Inc.
K863409	KUNDIN WOUND GAUGE	Sep 29, 1986	Substantially Equivalent	Jane I. Kundin
K862576	PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN)	Jul 15, 1986	Substantially Equivalent	Professional Services For Surgeons, Ltd.
K860912	PS2 BRAND MAMMAPLASTY	Mar 24, 1986	Substantially Equivalent	Professional Services For Surgeons, Ltd.
K854892	RULER	Dec 24, 1985	Substantially Equivalent	Euro-Med Intl.
K840651	MOLE-MARKER	Mar 12, 1984	Substantially Equivalent	Notation Systems, Inc.
K832899	ZIMMER OSSIMETER	Oct 14, 1983	Substantially Equivalent	Zimmer, Inc.
K831041	SAGITTAL KNEE TESTER	Jun 24, 1983	Substantially Equivalent	Orthopedic Systems, Inc.
K812713	DRAWER TEST	Nov 05, 1981	Substantially Equivalent	Medmetric Corp.
K812069	BORES* DEPTH GAUGE	Aug 31, 1981	Substantially Equivalent	Santa Barbara Medco, Inc.
K811278	EXTENDED TUMOR CALIPER	Jun 02, 1981	Substantially Equivalent	Mick Radio-Nuclear Instruments, Inc.
K801939	RHYTIDOMETER	Sep 26, 1980	Substantially Equivalent	Aztec Medical Products, Inc.
K801374	PROXIMATE (TMD) TISSUE MEASURING DEVICE	Jun 26, 1980	Substantially Equivalent	ETHICON, Inc.
K790660	SURGICAL RULER	Apr 12, 1979	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K790089	TAPE MEASURE	Mar 06, 1979	Substantially Equivalent	Pfizer, Inc.