Written and maintained by CASRAI Editorial Board
Last updated
Who uses it: clinicians and the clinic staff, sterile processing technicians and buyers who handle gynecologic instruments. This page describes products and general use; it is not medical advice.
An IUD removal hook is a long, slender, hook-ended hand instrument that FDA classifies as a Class I device and exempts from premarket notification. This page collects what the federal regulation and FDA device records say about the instrument and its variants; it does not describe how it is used on a patient.
What an IUD removal hook is
Under 21 CFR 884.4530(a)(10), “a hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.” It sits in a group of obstetric-gynecologic specialized manual instruments, which the same regulation says are used for manipulative diagnostic and surgical functions where “structural integrity is the chief criterion of device performance.” Related general background: what counts as a medical device.
How FDA regulates it
- Device name and product code: openFDA lists product code HHF as “Remover, Intrauterine Device, Contraceptive, Hook-Type” (checked 2026-10-31).
- Class: Class I, regulation number 884.4530. 21 CFR 884.4530(b)(2) names the IUD remover among the Class I devices that are exempt from the premarket notification (510(k)) procedures in subpart E of part 807, subject to the limitations in 21 CFR 884.9.
- Other flags in the classification record: not an implant, not life-sustaining or life-supporting, and not exempt from good manufacturing practice (GMP exempt flag N).
The IUD itself is a different device with its own regulation; see the contraceptive diaphragm guide for a neighboring contraceptive device class.
Types and lengths listed in FDA UDI records
FDA’s Global Unique Device Identification Database (GUDID) lists many instruments under product code HHF. The names used for hook designs include simple hook, universal hook and double extractor hook. The table shows examples as listed by each manufacturer, checked 2026-10-31. Listed lengths in these examples run from about 25 cm (10 in) to about 32 cm (12-3/4 in); several are described as malleable.
| Type (as named in the listing) | Brand | Listed description and length | Reuse and sterility field |
|---|---|---|---|
| Simple hook | V. Mueller (STERIS) | IUD removal hook, malleable, 10-1/4 in (26 cm) | Reusable; supplied non-sterile, sterilize before use |
| Simple hook | Marina Medical | Simple IUD hook, malleable, 4 mm, 25.5 cm | Reusable; supplied non-sterile, sterilize before use |
| Simple hook | Hayden Medical | Simple IUD hook, malleable, 10 in (25 cm) | Reusable; supplied non-sterile, sterilize before use |
| Simple hook | Novo Surgical (Zenith) | Simple hook, 10-1/4 in (26.0 cm) | Reusable; supplied non-sterile, sterilize before use |
| Simple hook | Novo Surgical | Simple hook, 10-1/4 in (26.0 cm) | Single-use; supplied non-sterile, sterilize before use |
| Universal hook | Novo Surgical (Zenith) | Universal hook, malleable, 12 in (30.5 cm) | Reusable; supplied non-sterile, sterilize before use |
| Double extractor hook | Hayden Medical | Double IUD extractor hook, 10-1/4 in (25.6 cm) | Reusable; supplied non-sterile, sterilize before use |
| Double extractor hook | Novo Surgical (Zenith) | Double extractor hook, 10-1/4 in (26.0 cm) | Reusable; supplied non-sterile, sterilize before use |
| Hook, named design | Aesculap | Saunders IUD removal hook, 12-3/4 in (320 mm) | Reusable; supplied non-sterile, sterilize before use |
| Hook, single-use | Instrapac (Robinson Healthcare) | IUD hook, 31 cm (12 in) | Single-use; supplied sterile |
| Forceps | Integra Miltex | Mathieu urethral and IUD removal forceps, 11-3/4 in shaft, serrated jaws 3.5 mm x 19 mm | Reusable; supplied non-sterile, sterilize before use |
Source for every row: FDA GUDID via the openFDA UDI endpoint, product code HHF. Descriptions are the manufacturers’ own wording.
IUD removal forceps versus hook
The regulation defines the hook-type remover as one device. Forceps-style products also appear under the same product code in GUDID, such as the Mathieu urethral and IUD removal forceps in the table. Searchers who type “IUD removal forceps” may therefore be looking at a different instrument shape; the product code alone does not distinguish them, so the listing description is the thing to read. Do not confuse either with the uterine tenaculum, which 21 CFR 884.4530 separately describes as a hooklike instrument used to seize and hold the cervix or fundus.
Reusable and single-use versions
Most listings above are reusable, are supplied non-sterile, and carry a GUDID field indicating they are to be sterilized prior to use. At least one listing is a single-use instrument supplied sterile. The GUDID fields do not give reprocessing parameters; those come from the manufacturer’s instructions for use. For the concept behind sterile supply, see sterility assurance level. A related instrument class is described in what a speculum is.
Common mistakes
- Treating product code HHF as meaning “hook only”: the code also carries forceps-style and other gynecologic instruments.
- Assuming reusable instruments arrive ready to use: the listings above say non-sterile, sterilize before use.
- Assuming Class I means no FDA requirements: the classification record shows the code is not GMP exempt.
FAQ
Is an IUD removal hook an FDA-regulated device?
Yes. It is a Class I device under 21 CFR 884.4530, product code HHF, exempt from 510(k) notification subject to the limitations in 21 CFR 884.9.
How long is an IUD removal hook?
Examples in FDA UDI records are listed at roughly 25 cm to 32 cm (10 in to 12-3/4 in); the table above gives each listing.
Are IUD removal hooks reusable?
Most listed examples are reusable and supplied non-sterile; at least one is single-use and supplied sterile. Check the specific product’s listing and instructions for use.
Medical supply catalogs list gynecologic instruments under gynecology and urology supplies.
Sources
- 21 CFR 884.4530, Obstetric-gynecologic specialized manual instrument: https://www.law.cornell.edu/cfr/text/21/884.4530 (checked 2026-10-31).
- openFDA device classification, product code HHF: https://api.fda.gov/device/classification.json?search=product_code:HHF (checked 2026-10-31). openFDA data are unvalidated and not for medical-care decisions.
- FDA GUDID via openFDA UDI endpoint, product code HHF: https://api.fda.gov/device/udi.json?search=product_codes.code:HHF (checked 2026-10-31).
