EZ-CIRC

K963223 · Phyllis Adams, Rn, Npc, Msn · HFW · Apr 23, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K963223
• Device Name: EZ-CIRC
• Applicant: Phyllis Adams, Rn, Npc, Msn
• Product Code: HFW · Obstetrics/Gynecology
• Decision Date: Apr 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

EZ-CIRC circumcision clamp; used for performing circumcisions. Device functions as a mechanical clamp to facilitate the procedure. Used by clinicians in a clinical setting. Provides a means to secure tissue during circumcision.

Clinical Evidence

No clinical data provided; substantial equivalence based on predicate device comparison.

Technological Characteristics

Mechanical circumcision clamp; design and function equivalent to predicate Mogan clamp.

Indications for Use

Indicated for use as a circumcision clamp.

Regulatory Classification

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.

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.

Predicate Devices

• Mogan Clamp

Submission Summary (Full Text)

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APR 23 1997
1<963223

510(k) Summary

The safety and effectiveness information upon which the substantial
equivalence determination is based on the Mogan clamp. This
clamp is a predicate device that was legally marketed in the United
States prior to May 28, 1976.

Submitter's name: Frederic Steinberg, DO
40 Cooper Run Drive
Cherry Hill, NJ 08003
[phone]

and

Phyllis Adams, RN, NPC, MSN
27 Lady Diana Circle
Marlton, NJ 08053
[phone]

Fax Number: [phone]
Attention: Phyllis Adams

Contact Person: Phyllis Adams
27 Lady Diana Circle
Marlton, NJ 08053

Date of Summary: November 8, 1995/
January 31, 1997

Name of Device: Trade Name:
EZ-CIRC

Common Name:
Circumcision Clamp

Classification Name:
Obstetrical and Gynecological
Devices (884.4520)

Identification of legally marketed device which claiming equivalence: Mogan Clamp

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