HTD · Forceps
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | HTD |
|---|---|
| Device Name | Forceps |
| Regulation | 21 CFR 878.4800 |
| Device Class | Class 1 |
| Review Panel | General, 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.
Cleared Devices (73)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K051281 | THE NEEDLE CATCHER | E.D.Medical , Ltd. | Sep 8, 2005 | SESE |
| K974595 | CUSHING BAYONET, INSULATED BIPOLAR FORCEP | Titan Mfg., Inc. | Jun 24, 1998 | SESE |
| K974594 | SEMKIN BIPOLAR FORCEP | Titan Mfg., Inc. | Jun 24, 1998 | SESE |
| K974593 | SEMKIN INSULATED BIPOLAR FORCEP | Titan Mfg., Inc. | Jun 24, 1998 | SESE |
| K913964 | MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS | Marlo Surgical Technology | Oct 23, 1991 | SESE |
| K911180 | CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS | Northgate Technologies, Inc. | Mar 29, 1991 | SESE |
| K895212 | TIK EXTRAKTOR | Instruments of Sweden, Inc. | Sep 27, 1989 | SESE |
| K890373 | HEMORRHOIDAL FORCEPS | Kinetic Medical Products | Feb 3, 1989 | SESE |
| K890369 | GALL STONE FORCEPS | Kinetic Medical Products | Feb 3, 1989 | SESE |
| K890263 | CILIA FORCEPS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890262 | LUNG FORCEPS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890260 | BONE SHEARS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890259 | RIB SHEARS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890258 | BONE CUTTING FORCEPS, SINGLE-ACTION | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890257 | BONE CUTTING FORCEPS, DOUBLE-ACTION | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890246 | ARTERY FORCEPS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890244 | TUBING CLAMP FORCEPS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890238 | CATHETER FORCEPS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890234 | SUTURE CLIP REMOVER | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890226 | SURGICAL FORCEPS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890213 | MICROSURGICAL FORCEPS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K874965 | MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE | Solway, Inc. | Dec 30, 1987 | SESE |
| K874950 | MICROSURGICAL INSTRUMENTS | Solway, Inc. | Dec 30, 1987 | SESE |
| K874023 | LEVTECH CLAMP APPLIER | Levtech, Inc. | Nov 6, 1987 | SESE |
| K873513 | SERRATED GRASPING FORCEPS, CURVED UP | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873512 | SERRATED GRASPING FORCEPS, RIGHT | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873511 | SERRATED GRASPING FORCEPS, LEFT | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873510 | SERRATED GRASPING FORCEPS, CURVED DOWN | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873506 | CUP BIOPSY FORCEPS, CURVED UP | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873505 | CUP BIOPSY FORCEPS, CURVED DOWN | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873504 | CUP BIOPSY FORCEPS, RIGHT | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873503 | CUP BIOPSY FORCEPS, LEFT | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K871535 | SMILJANIC BONE REPOSITIONING FORCEPS | Link America, Inc. | May 14, 1987 | SESE |
| K870881 | LOOSE BODY GRASPERS | Bowen & Company, Inc. | Mar 23, 1987 | SESE |
| K852729 | AALSTEAD MOSQ. FORCEPS, STRAIGHT, 5+SS 410 OR 420 | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K852728 | KELLY HEMOSTATIC FORCEPS, STRAIGHT 5-1/2+SS | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K852727 | ROCHESTER - PEAN FORCEPS, STRAIGHT, 6-1/4+SS | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K852723 | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K852722 | STERILIZING FORCEPS, 3-PRONGE, 11+SS 410 OR 420 | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K852720 | THUMB DRESSING FORCEPS, 5+SS 410 OR 420 | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K852718 | ADSON TISSUE FORCEPS, 1X2 TEETH 4-3/4+SS | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K852715 | MAGILL FORCEPS, ADULT, 10 + SS 410 OR 420 | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K852713 | RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420 | The Huxley Instrument Corp. | Jul 15, 1985 | SESE |
| K851770 | VARIOUS DRESSING TISSUE FROCEPS(GILLIES, JEANS, RA | Artiberia | Jun 20, 1985 | SESE |
| K851769 | VARIOUS DRESSING/TISSUE FORCEPS(ENGLISH, THUMB, TR | Artiberia | Jun 20, 1985 | SESE |
| K842819 | HOOK PUNCH FORCEPS FOR ARTHROSCOPY | Medtech Industries, Inc. | Aug 14, 1984 | SESE |
| K834367 | SUTURE REMOVAL WOUND CLOSURE-INSTRU- | Sterling Multi-Products, Inc. | May 30, 1984 | SESE |
| K840304 | CATEGORY 17-MICROBIOLOGY DEVICES | Imm Enterprises , Ltd. | May 1, 1984 | SESE |
| K840766 | JANACEK TUBO-UTERINE IMPLANTATION SET | Cimed Intl., Inc. | Apr 23, 1984 | SESE |
| K840318 | CAT. 14-CLINICAL TOXIOLOGY DEVICES | Imm Enterprises , Ltd. | Apr 23, 1984 | SESE |
| K840320 | CAT. 16-IMMUNOLOGY DEVICES | Imm Enterprises , Ltd. | Mar 12, 1984 | SESE |
| K840319 | CAT 15-HEMATOLOGY & PATHOLOGY DEVICE | Imm Enterprises , Ltd. | Mar 12, 1984 | SESE |
| K840317 | CAT 13-CLINICAL CHEMISTRY DEVICES | Imm Enterprises , Ltd. | Mar 12, 1984 | SESE |
| K840316 | CAT 12-ORTHOPEDIC & REHAB DEVICE | Imm Enterprises , Ltd. | Mar 12, 1984 | SESE |
| K840315 | CAT 11- GENERAL & PLASTIC SURGERY DEV | Imm Enterprises , Ltd. | Mar 12, 1984 | SESE |
| K840309 | CAT. 5-RADIOLOGY DEVICES | Imm Enterprises , Ltd. | Mar 12, 1984 | SESE |
| K840307 | CAT. 3 GASTROENTEROLOGY-UROLOGY DEV | Imm Enterprises , Ltd. | Mar 12, 1984 | SESE |
| K840306 | CATEGORY 2 GEN. HOSPITAL & PERSONAL USE | Imm Enterprises , Ltd. | Mar 12, 1984 | SESE |
| K833629 | CERTAIN MANUAL SURG. INSTRU. ACCESS | Cimed Intl., Inc. | Jan 30, 1984 | SESE |
| K834542 | H.R. JAKOBI SURG. INSTRU. SECT. 48 | Imm Enterprises , Ltd. | Jan 27, 1984 | SESE |
| K834185 | JAKOBI SURG. INSTRUMENTS #11 14/45 | Imm Enterprises , Ltd. | Jan 27, 1984 | SESE |
| K834183 | H.R. JAKOBI SURG. INSTRUMENTS #11 25/39 | Imm Enterprises , Ltd. | Jan 27, 1984 | SESE |
| K834180 | H.R. JAKOBI SURG. INSTRUMENTS #11 13/20 | Imm Enterprises , Ltd. | Jan 27, 1984 | SESE |
| K831138 | CURVED HEMOSTAT 5 | Almore Intl., Inc. | May 18, 1983 | SESE |
| K831137 | STRAIGHT 5 HEMOSTAT | Almore Intl., Inc. | May 18, 1983 | SESE |
| K821298 | BACKHAUS CLAMP, 3 1/2 | Conphar, Inc. | May 28, 1982 | SESE |
| K821293 | BACKHAUS CLAMP, 5 1/4 | Conphar, Inc. | May 28, 1982 | SESE |
| K820344 | ROWE SHOULDER INSTR. FOR BANKHART REPAIR | New England Surgical Instrument Corp. | Mar 8, 1982 | SESE |
| K802676 | ORHTOPEDIC REAMER 87 HTD | Zimmer, Inc. | Nov 12, 1980 | SESE |
| K800273 | ACUFEX FORCEPS | Acufex Microsurgical, Inc. | Feb 19, 1980 | SESE |
| K771097 | FORCEP, DISP., A CLAMP | Dravon Medical, Inc. | Jul 14, 1977 | SESE |
| K771192 | LOWMAN BONE FORCEP | Edward Weck, Inc. | Jul 11, 1977 | SESE |
| K770206 | GRASPING FORCEPS | Depuy, Inc. | Feb 8, 1977 | SESE |
Top Applicants
- Kinetic Medical Products — 14 clearances
- Imm Enterprises , Ltd. — 14 clearances
- The Huxley Instrument Corp. — 9 clearances
- Arthropedics, Inc. — 8 clearances
- Titan Mfg., Inc. — 3 clearances
