Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4530](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4530) → LKF — Cannula, Manipulator/Injector, Uterine # LKF · Cannula, Manipulator/Injector, Uterine _Obstetrics/Gynecology · 21 CFR 884.4530 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF ## Overview - **Product Code:** LKF - **Device Name:** Cannula, Manipulator/Injector, Uterine - **Regulation:** [21 CFR 884.4530](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4530) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **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. ## Recent Cleared Devices (20 of 87) Showing 20 most recent of 87 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253403](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K253403.md) | FemVue® Controlled Saline-Air Device (FSA-300) | Femasys, Inc. | Dec 15, 2025 | SESE | | [K252260](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K252260.md) | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. | Nov 26, 2025 | SESE | | [K242002](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K242002.md) | FemVue MINI Saline-Air Device | Femasys, Inc. | Nov 22, 2024 | SESE | | [K240364](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K240364.md) | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | Li Medical Corporation , Ltd. | Oct 16, 2024 | SESE | | [K241693](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K241693.md) | FemChec Controlled Saline-Air Device (FCD-250) | Femasys, Inc. | Sep 6, 2024 | SESE | | [K222798](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K222798.md) | Rejoni Intrauterine Catheter | Rejoni, Inc. | Dec 16, 2022 | SESE | | [K223064](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K223064.md) | ALLY II Uterine Positioning System™ (UPS) | CooperSurgical, Inc. | Oct 28, 2022 | SESE | | [K220202](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K220202.md) | Uterine ElevatOR PRO with OccludOR Balloon | The O R Company Pty, Ltd. | Mar 31, 2022 | SESE | | [K212505](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K212505.md) | DUMI ManipulatOR | The O R Company Pty, Ltd. | Jan 10, 2022 | SESE | | [K181770](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K181770.md) | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | Mar 29, 2019 | SESE | | [K180300](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K180300.md) | Margolin HSG Cannula, Goldstein Sonohysterography Catheter | Cook Incorporated | Oct 26, 2018 | SESE | | [K180291](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K180291.md) | Cook Silicone Balloon HSG Catheter | Cook Incorporated | Oct 26, 2018 | SESE | | [K172846](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K172846.md) | Uterine Manipulator | Beijing Hangtian Kadi Technology R&D Institute | Jun 26, 2018 | SESE | | [K171604](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K171604.md) | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip | Cook Incorporated | Feb 15, 2018 | SESE | | [K163214](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K163214.md) | Unicare System, Unicare Manipulator | Clearpath Surgical, Inc. | Feb 7, 2017 | SESE | | [K160217](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K160217.md) | uVue HSG/SHG Catheter | Cook Incorporated | Oct 6, 2016 | SESE | | [K153092](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K153092.md) | Ally Uterine Positioning System | CooperSurgical, Inc. | Dec 21, 2015 | SESE | | [K150519](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K150519.md) | ManipulatOR PRO, ManipulatOR | Gynetech Pty. , Ltd. | Aug 19, 2015 | SESE | | [K142545](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K142545.md) | SonoFlow Sonohysterography and Sonohysterosalpingography Device | Crossbay Medical, Inc. | Mar 20, 2015 | SESE | | [K143415](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF/K143415.md) | Air Bubble Based Infuser (ABBI) | CooperSurgical, Inc. | Feb 26, 2015 | SESE | ## Top Applicants - Femasys, Inc. — 7 clearances - Ackrad Laboratories — 6 clearances - Cook Incorporated — 5 clearances - Catheter Research, Inc. — 4 clearances - CooperSurgical, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LKF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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