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A cervical ripening balloon is a sterile, single-use silicone double balloon catheter that a clinician uses for mechanical dilation of the cervical canal before labor induction at term. This reference summarizes the manufacturer’s instructions for use (IFU) facts that matter to buyers and students (construction, versions, supply and storage) and the device’s FDA classification record. It leaves out procedure steps and clinical guidance.
What is a cervical ripening balloon (and “Cook’s balloon”)?
“Cook’s balloon” is the common shorthand for the Cook Cervical Ripening Balloon from Cook Medical. Its IFU describes it as a silicone double balloon catheter and states it is “indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.” In the United States it is labelled for sale by or on the order of a physician or properly licensed practitioner.
Who uses it: the label directs it to licensed clinicians in obstetric care. Supply staff, students and buyers meet it as a sterile, single-use catheter. For a comparison with a different, non-balloon cervical dilator, see the laminaria guide. For how cervical status is scored in obstetrics, see the Bishop score guide.
How is the double balloon built?
The device is a catheter with two silicone balloons, which the IFU calls the uterine balloon and the vaginal balloon. Each has its own color-coded Check-Flo inflation valve (red, marked U, and green, marked V), and the IFU names a standard 20 mL Luer-lock syringe as the matching syringe type. The stylet version adds a malleable stylet that connects through a blue port marked S.
The IFU gives a maximum balloon capacity of 80 mL per balloon.
What is the difference between the versions with and without a stylet?
Cook publishes two IFUs for the device. They are identical on description, capacity and supply, except that one version includes the stylet.
| Item | With stylet (IFU T_J-CCRBS_REV3) | Without stylet (IFU T_J-CCRB_REV2) |
|---|---|---|
| Description | Silicone double balloon catheter with a malleable stylet | Silicone double balloon catheter |
| Maximum balloon capacity | 80 mL per balloon | 80 mL per balloon |
| Intended use | Mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable | Same wording |
| Supply | Ethylene oxide sterilized, peel-open package, one-time use | Same |
| Storage | Dark, dry, cool place; avoid extended light | Same |
Source: Cook Medical IFUs (see Sources), date checked 2026-10-30.
What are the FDA classification and product code PON?
The openFDA device classification database lists product code PON as “Catheter, Balloon, Dilation Of Cervical Canal”: device class 2, review panel Obstetrics/Gynecology, definition “Mechanical dilation and softening of the cervix,” with regulation number 884.4260 as recorded by that classification entry (data checked 2026-10-30).
Product code PON is a classification grouping, not one product. openFDA also lists other 510(k) clearances under PON, among them the Aqueduct and CrossBay cervical dilator catheter systems, which are described as cervical dilation catheters for gynecologic procedures. A buyer or student should not assume that every PON-coded balloon catheter shares a labor-induction intended use; check the intended use in each product’s own IFU. For general background on how the FDA handles device events and device law, see medical device reporting (MDR) and the Medical Device Amendments of 1976.
What does the label say about supply and handling?
| Topic | What the Cook IFU says |
|---|---|
| Material | Silicone double balloon catheter |
| Sterility and reuse | Ethylene oxide sterilized, peel-open package, one-time use; do not use the product if there is doubt that it is sterile. |
| Storage | Store in a dark, dry, cool place and avoid extended exposure to light. |
| Receiving | Inspect the product on removal from the package to ensure no damage has occurred. |
| Sale | US federal law restricts sale to or on the order of a physician or properly licensed practitioner. |
Source: Cook Cervical Ripening Balloon with Stylet IFU (T_J-CCRBS_REV3), date checked 2026-10-30. Clinical use, warnings and contraindications are in the full IFU supplied with the product and belong to licensed clinicians.
What are common mistakes when reading about this device?
- Treating every PON-coded balloon as the same device. The code groups devices with different intended uses.
- Using the wrong IFU. The stylet and non-stylet versions have separate IFUs.
- Reusing a single-use device. The label says one-time use.
Frequently asked questions
What is Cook’s balloon?
It is shorthand for the Cook Cervical Ripening Balloon, a silicone double balloon catheter from Cook Medical indicated for mechanical dilation of the cervical canal before labor induction at term.
What is the maximum capacity of each balloon?
The IFU gives a maximum balloon capacity of 80 mL per balloon for both versions.
Is it a Class 2 device?
openFDA lists product code PON, “Catheter, Balloon, Dilation Of Cervical Canal,” as device class 2 in the Obstetrics/Gynecology panel.
Is it single use?
Yes. The IFU says it is supplied sterilized by ethylene oxide gas in peel-open packages and is intended for one-time use.
Sources
- Cook Medical, Cook Cervical Ripening Balloon with Stylet IFU, T_J-CCRBS_REV3: https://ifu.cookmedical.com/data/IFU_PDF/T_J-CCRBS_REV3.PDF, date checked 2026-10-30.
- Cook Medical, Cook Cervical Ripening Balloon IFU, T_J-CCRB_REV2: https://ifu.cookmedical.com/data/IFU_PDF/T_J-CCRB_REV2.PDF, date checked 2026-10-30.
- U.S. FDA, openFDA device classification, product code PON: https://api.fda.gov/device/classification.json?search=product_code:PON, date checked 2026-10-30.
Related supplies: gynecology and urology supplies.
