HTD · Forceps

General, Plastic Surgery · 21 CFR 878.4800 · Class 1

Overview

Product CodeHTD
Device NameForceps
Regulation21 CFR 878.4800
Device ClassClass 1
Review PanelGeneral, Plastic Surgery

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Recent Cleared Devices (20 of 73)

Showing 20 most recent of 73 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K051281THE NEEDLE CATCHERE.D.Medical , Ltd.Sep 8, 2005SESE
K974595CUSHING BAYONET, INSULATED BIPOLAR FORCEPTitan Mfg., Inc.Jun 24, 1998SESE
K974594SEMKIN BIPOLAR FORCEPTitan Mfg., Inc.Jun 24, 1998SESE
K974593SEMKIN INSULATED BIPOLAR FORCEPTitan Mfg., Inc.Jun 24, 1998SESE
K913964MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPSMarlo Surgical TechnologyOct 23, 1991SESE
K911180CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPSNorthgate Technologies, Inc.Mar 29, 1991SESE
K895212TIK EXTRAKTORInstruments of Sweden, Inc.Sep 27, 1989SESE
K890373HEMORRHOIDAL FORCEPSKinetic Medical ProductsFeb 3, 1989SESE
K890369GALL STONE FORCEPSKinetic Medical ProductsFeb 3, 1989SESE
K890263CILIA FORCEPSKinetic Medical ProductsJan 27, 1989SESE
K890262LUNG FORCEPSKinetic Medical ProductsJan 27, 1989SESE
K890260BONE SHEARSKinetic Medical ProductsJan 27, 1989SESE
K890259RIB SHEARSKinetic Medical ProductsJan 27, 1989SESE
K890258BONE CUTTING FORCEPS, SINGLE-ACTIONKinetic Medical ProductsJan 27, 1989SESE
K890257BONE CUTTING FORCEPS, DOUBLE-ACTIONKinetic Medical ProductsJan 27, 1989SESE
K890246ARTERY FORCEPSKinetic Medical ProductsJan 27, 1989SESE
K890244TUBING CLAMP FORCEPSKinetic Medical ProductsJan 27, 1989SESE
K890238CATHETER FORCEPSKinetic Medical ProductsJan 27, 1989SESE
K890234SUTURE CLIP REMOVERKinetic Medical ProductsJan 27, 1989SESE
K890226SURGICAL FORCEPSKinetic Medical ProductsJan 27, 1989SESE

Top Applicants

Innolitics

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