Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: HTD FDA class 1

Forceps

General, Plastic Surgery

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Forceps are handheld surgical instruments with two opposing blades used to grasp, hold, or manipulate tissue and other materials during surgical procedures. They are classified as an FDA Class 1 device under 21 CFR 878.4800, indicating the lowest level of risk and general controls only. Product code HTD falls under the General and Plastic Surgery medical specialty.

510(k) Clearances

50+ matches
K Number
Device Name
THE NEEDLE CATCHER
SEMKIN BIPOLAR FORCEP
CUSHING BAYONET, INSULATED BIPOLAR FORCEP
SEMKIN INSULATED BIPOLAR FORCEP
MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS
CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS
TIK EXTRAKTOR
GALL STONE FORCEPS
HEMORRHOIDAL FORCEPS
SUTURE CLIP REMOVER
CILIA FORCEPS
ARTERY FORCEPS
BONE CUTTING FORCEPS, SINGLE-ACTION
RIB SHEARS
BONE CUTTING FORCEPS, DOUBLE-ACTION
TUBING CLAMP FORCEPS
BONE SHEARS
CATHETER FORCEPS
SURGICAL FORCEPS
LUNG FORCEPS
MICROSURGICAL FORCEPS
MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE
MICROSURGICAL INSTRUMENTS
LEVTECH CLAMP APPLIER
CUP BIOPSY FORCEPS, RIGHT
SERRATED GRASPING FORCEPS, RIGHT
SERRATED GRASPING FORCEPS, LEFT
CUP BIOPSY FORCEPS, CURVED UP
CUP BIOPSY FORCEPS, CURVED DOWN
SERRATED GRASPING FORCEPS, CURVED UP
CUP BIOPSY FORCEPS, LEFT
SERRATED GRASPING FORCEPS, CURVED DOWN
SMILJANIC BONE REPOSITIONING FORCEPS
LOOSE BODY GRASPERS
THUMB DRESSING FORCEPS, 5+SS 410 OR 420
AALSTEAD MOSQ. FORCEPS, STRAIGHT, 5+SS 410 OR 420
RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420
ROCHESTER - PEAN FORCEPS, STRAIGHT, 6-1/4+SS
MAGILL FORCEPS, ADULT, 10 + SS 410 OR 420
STERILIZING FORCEPS, 3-PRONGE, 11+SS 410 OR 420
FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420
ADSON TISSUE FORCEPS, 1X2 TEETH 4-3/4+SS
KELLY HEMOSTATIC FORCEPS, STRAIGHT 5-1/2+SS
VARIOUS DRESSING TISSUE FROCEPS(GILLIES, JEANS, RA
VARIOUS DRESSING/TISSUE FORCEPS(ENGLISH, THUMB, TR
HOOK PUNCH FORCEPS FOR ARTHROSCOPY
SUTURE REMOVAL WOUND CLOSURE-INSTRU-
CATEGORY 17-MICROBIOLOGY DEVICES
JANACEK TUBO-UTERINE IMPLANTATION SET
CAT. 14-CLINICAL TOXIOLOGY DEVICES

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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