HFW · Clamp, Umbilical
Obstetrics/Gynecology · 21 CFR 884.4530 · Class 2
Overview
| Product Code | HFW |
|---|---|
| Device Name | Clamp, Umbilical |
| Regulation | 21 CFR 884.4530 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041332 | JOEY CLAMP OPENING TOOL | Maternus, Inc. | Jun 25, 2004 | SESE |
| K033846 | KAEN YIH UMBILICAL CORD CLAMP | Kaen Yih Enterprise Co., Ltd. | Mar 11, 2004 | SESE |
| K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | Precision Dynamics Corp. | Jun 3, 2002 | SESE |
| K021055 | BUSSE UMBILICAL CORD CLAMP CUTTER | Busse Hospital Disposables, Inc. | Apr 29, 2002 | SESE |
| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | Dynarex Corp. | Nov 28, 2001 | SESE |
| K011621 | KOALA CLAMP, KOALA CLAMP AND CUTTER | Maternus, Inc. | Aug 10, 2001 | SESE |
| K010695 | KOALA CLAMP | Maternus, Inc. | May 3, 2001 | SESE |
| K010835 | POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 | Busse Hospital Disposables, Inc. | Apr 30, 2001 | SESE |
| K000227 | UMBICUT | Pollak (Intl.), Ltd. | Apr 27, 2000 | SESE |
| K994367 | UMBILICAL CORD CLAMP | Medical Sales Co. | Mar 17, 2000 | SESE |
| K994263 | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 | Precision Dynamics Corp. | Jan 24, 2000 | SESE |
| K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 | Precision Dynamics Corp. | Apr 6, 1999 | SESE |
| K983204 | HARWILL MEDICAL U-KLIP UMBILICAL CLAMP | Harwill Medical (Pty) , Ltd. | Feb 26, 1999 | SESE |
| K974227 | HOSPITAL'S CLAMP | Gps | Dec 12, 1997 | SESE |
| K963223 | EZ-CIRC | Phyllis Adams, Rn, Npc, Msn | Apr 23, 1997 | SESE |
| K963889 | QFC UMBILICAL CLAMP | Qfc Industries | Apr 18, 1997 | SESE |
| K963428 | UMBILICAL CLAMP AND CUTTER | R.O.S.T. Medical Development, Inc. | Apr 1, 1997 | SESE |
| K945841 | BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP | W G M Corp. | May 30, 1995 | SESE |
| K951140 | KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR | Balagan Medical, Inc. | May 25, 1995 | SESE |
| K933763 | SAVE-T-BREATH AMBILICAL CORD CLAMP | Save-T-Breath Distributors C.C. | Aug 29, 1994 | SESE |
Top Applicants
- Precision Dynamics Corp. — 3 clearances
- Maternus, Inc. — 3 clearances
- Hollister, Inc. — 2 clearances
- Busse Hospital Disposables, Inc. — 2 clearances
- Welcon, Inc. — 1 clearance
