GDF · Guide, Needle, Surgical
General, Plastic Surgery · 21 CFR 878.4800 · Class 1
Overview
| Product Code | GDF |
|---|---|
| Device Name | Guide, Needle, Surgical |
| 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 (28)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K031173 | NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 | Needle Tech Products, Inc. | Jul 23, 2003 | SESE |
| K950311 | GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE | Global Medical Products, Ltd. | May 26, 1995 | SESE |
| K950007 | SURGICAL INSTRUMENT GUIDE | United States Surgical, A Division of Tyco Healthc | Mar 15, 1995 | SESE |
| K945124 | BREAST LESION LOCALIZATION NEEDLE | Promex, Inc. | Nov 22, 1994 | SESE |
| K944942 | BREAST LESION LOCALIZATION NEEDLE | Promedical , Ltd. | Nov 4, 1994 | SESE |
| K935538 | BAUER TEMNO COAXIAL NEEDLE | Bauer Medical, Inc. | Feb 22, 1994 | SESE |
| K935457 | LOCALIZATION WIRE OR MARKER - SURGICAL | Bip USA, Inc. | Feb 17, 1994 | SESE |
| K923840 | NEEDLE-GRABBER | Guardian Angel Products, Inc. | Jul 13, 1993 | SESE |
| K923835 | THE ELEVENTH FINGER | Guardian Angel Products, Inc. | Jul 9, 1993 | SESE |
| K925875 | HORIZONTAL NEEDLE GUIDE ATTACHMENT | Bip USA, Inc. | Apr 6, 1993 | SESE |
| K924270 | BREAST LESION LOCALIZATION NEEDLE | Core Medical, Inc. | Sep 23, 1992 | SESE |
| K923120 | MICROGUIDE LESION MARKING SYSTEM | Angiodynamics, Div. E-Z-Em, Inc. | Sep 1, 1992 | SESE |
| K914941 | SIMON BREAST LESION LOCALIZATION NEEDLE | Manan Medical Products, Inc. | May 14, 1992 | SESE |
| K920816 | PERCUGUIDE LESION MARKING | E-Z-Em, Inc. | Apr 21, 1992 | SESE |
| K904172 | ACCUPLACE (TM) | Dlp, Inc. | Nov 21, 1990 | SESE |
| K900903 | KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE | Milex Products, Inc. | May 3, 1990 | SESE |
| K890229 | SURGICAL NEEDLE HOLDERS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890228 | SURGICAL NEEDLE GUIDE | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K890211 | MICROSURGICAL NEEDLE HOLDERS | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K882036 | WILLIAMS ACS MARKER NEEDLE | Buckman Co., Inc. | Jul 27, 1988 | SESE |
| K864551 | BIOPSY ADAPTER #H4221BG | General Electric Co. | Dec 23, 1986 | SESE |
| K863090 | PERCU GUIDE I (LOOP TYPE) | E-Z-Em, Inc. | Aug 29, 1986 | SESE |
| K861050 | BIOPSY ADAPTER H4222W | General Electric Co. | Apr 2, 1986 | SESE |
| K845038 | BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT | Ranfac, Corp. | Mar 11, 1985 | SESE |
| K832978 | MENISCAL SUTURE GUN | Instrument Makar, Inc. | Dec 12, 1983 | SESE |
| K821354 | CONPHAR MAYO HEGAR NEEDLE HOLDER | Conphar, Inc. | Jun 3, 1982 | SESE |
| K821295 | OLSEN HEGAR NEEDLE HOLDERS | Conphar, Inc. | Jun 3, 1982 | SESE |
| K821289 | MAYO-HEGAR NEEDLE HOLDER | Conphar, Inc. | Jun 3, 1982 | SESE |
Top Applicants
- Kinetic Medical Products — 3 clearances
- Conphar, Inc. — 3 clearances
- Guardian Angel Products, Inc. — 2 clearances
- General Electric Co. — 2 clearances
- E-Z-Em, Inc. — 2 clearances
