HCZ · Forceps, Surgical, Gynecological
Obstetrics/Gynecology · 21 CFR 884.4530 · Class 2
Overview
| Product Code | HCZ |
|---|---|
| Device Name | Forceps, Surgical, Gynecological |
| Regulation | 21 CFR 884.4530 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
Classification Rationale
(1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Special Controls
*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Cleared Devices (24)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172661 | Fetzer Medical Gynecological Forceps | Fetzer Medical GmbH & Co. KG | May 8, 2018 | SESE |
| K134047 | JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS | Integra LifeSciences Corporation | Apr 11, 2014 | SESE |
| K092840 | INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL | Instrumed International, Inc. | Dec 3, 2009 | SESE |
| K944055 | FORCEPS, SURGICAL GYNECOLOGICAL | Owens Precision Systems, Inc. | Sep 20, 1994 | SESE |
| K941528 | PEARL PACKING FORCEPS | Cook Urological, Inc. | May 12, 1994 | SESE |
| K926533 | Z-CLAMP FORCEPS | Thomasville Medical Assoc. | Feb 25, 1994 | SESE |
| K926531 | HYSTERECTOMY FORCEPS | Thomasville Medical Assoc. | Feb 25, 1994 | SESE |
| K926484 | CORSON MYOMA GRASPING FORCEPS | Thomasville Medical Assoc. | Feb 25, 1994 | SESE |
| K930799 | VARIOUS FORCEPS | Thomasville Medical Assoc. | Feb 24, 1994 | SESE |
| K930039 | FORCEPS: MCGRAVEY, MCINDOE, GILLIS | Thomasville Medical Assoc. | Feb 24, 1994 | SESE |
| K926528 | OVUM FORCEPS | Thomasville Medical Assoc. | Feb 24, 1994 | SESE |
| K911474 | LAPAROSCOPIC FORCEPS | United States Endoscopy Group, Inc. | Jul 3, 1991 | SESE |
| K903707 | DEFLECTING WIRE GRASPER | Cook, Inc. | Sep 26, 1990 | SESE |
| K901897 | ZEPPELIN FORCEPS | Kirwan Surgical Products, Inc. | Jun 29, 1990 | SESE |
| K892820 | FORCEPS, SURGICAL, GYNECOLOGICAL | The South India Surgical Co. Pvt. , Ltd. | Jun 22, 1989 | SESE |
| K891047 | ZEPPELIN FORCEPS | Zinnanti Surgical Instruments, Inc. | Mar 17, 1989 | SESE |
| K891036 | HYSTERECTOMY FORCEPS - (SEVERAL MODELS) | Zinnanti Surgical Instruments, Inc. | Mar 17, 1989 | SESE |
| K890383 | HYSTERECTOMY FORCEPS | Kinetic Medical Products | Feb 16, 1989 | SESE |
| K890386 | PLACENTA AND OVUM FORCEPS | Kinetic Medical Products | Feb 13, 1989 | SESE |
| K890378 | UTERINE DRESSING FORCEPS | Kinetic Medical Products | Feb 13, 1989 | SESE |
| K852721 | BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 | The Huxley Instrument Corp. | Sep 6, 1985 | SESE |
| K834174 | OP-CON SURGICAL INSTRUMENTS #4 | Imm Enterprises , Ltd. | Dec 27, 1983 | SESE |
| K810391 | VOGLER HYSTERECTOMY FORCEPS (SMALL & LG) | Edward Weck, Inc. | Mar 4, 1981 | SESE |
| K772229 | MINICLAMPS, STABILIZ., FALLOPIAN TUBE | J. Sklar Mfg. Co., Inc. | Jan 3, 1978 | SESE |
Top Applicants
- Thomasville Medical Assoc. — 6 clearances
- Kinetic Medical Products — 3 clearances
- Zinnanti Surgical Instruments, Inc. — 2 clearances
- United States Endoscopy Group, Inc. — 1 clearance
- The South India Surgical Co. Pvt. , Ltd. — 1 clearance
