Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information only. This page is not medical advice and does not describe surgical technique.
Short answer
A cystotome is a manual, handheld ophthalmic surgical instrument with a sharp, bent tip, used in cataract surgery to puncture the anterior lens capsule. In the United States it is a Class I device under 21 CFR 886.4350 (FDA product code HNY), exempt from premarket notification. The same word also names an unrelated electrosurgical gastrointestinal device.
What is a cystotome? Definition and scope
Federal regulation names the cystotome directly. 21 CFR 886.4350 defines a manual ophthalmic surgical instrument as “a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures,” and lists the cystotome among the instruments in that generic type (eCFR, checked 2026-10-31).
The FDA classification database carries it as its own product code. The openFDA record for product code HNY gives the device name “Cystotome,” device class 1, regulation number 886.4350 and medical specialty Ophthalmic (openFDA, checked 2026-10-31). The record’s definition field is blank, so the regulation text above is the authoritative description.
Class I means general controls apply. The regulation states the device is exempt from the premarket notification procedures in subpart E of 21 CFR Part 807, subject to the limitations in 21 CFR 886.9. Exemption from 510(k) is a statement about premarket review, not about quality or suitability, and it does not remove the manufacturer’s other obligations under general controls.
What the instrument is and how it pairs with forceps
The Boston University Eye Associates “Phaco Primer” (checked 2026-10-31) describes the cystotome in its capsulorhexis chapter as a sharp-tipped instrument with a bent shaft, designed to puncture the anterior capsule. The same educational page says pre-bent cystotome needles are available, and that many surgeons use a second instrument, Utrata-type capsulorhexis forceps (the primer spells it “Utrada”), to handle the capsular flap. It also notes forceps with a sharp tip that some surgeons use in place of a separate cystotome.
Technique is a clinical matter for trained surgeons and is outside the scope of this page. For the forceps side of the pairing, see what Utrata forceps are.
Cystotome and same-name or neighbouring devices
Searches for “cystotome” return more than one kind of device. Each row below traces to a cited source.
| Item | What the source says | Source |
|---|---|---|
| Ophthalmic cystotome | Manual, nonpowered, handheld; listed in the 886.4350 generic type; FDA product code HNY, Class I; sharp, bent tip for the anterior capsule. | 21 CFR 886.4350; openFDA; BU Phaco Primer |
| Needle-based cystotome | Available pre-bent. | BU Phaco Primer |
| Sharp-tipped Utrata-style forceps | A forceps design the primer describes as removing the need for a separate cystotome. | BU Phaco Primer |
| Cook Medical Cystotome (CST-10, 190 cm) | A gastrointestinal device developed to electrosurgically cannulate the transgastric or transduodenal wall into a pancreatic pseudocyst; described as sterile and designed for single use. | Manufacturer listing mirrored on HealthManagement.org |
The Cook device is not an ophthalmic instrument and falls outside the ophthalmic regulation 886.4350. This page does not state its FDA classification.
Where it matters for labs, clinics and supply decisions
When a cystotome appears on a requisition, formulary or supplier catalogue, four distinctions are worth making explicit in the item description:
- Which specialty. An ophthalmic cystotome and a gastrointestinal cystotome share a name and nothing else in the cited sources. Record the specialty with the item.
- Regulatory identity. For the ophthalmic instrument, the identifiers are 21 CFR 886.4350 and product code HNY, Class I. These are useful search keys in FDA databases such as the classification and device listing records.
- Pre-bent or not. The BU primer notes that pre-bent cystotome needles are available. This page does not endorse any format as a purchasing standard.
- Reuse status. The only single-use statement in the cited sources belongs to the Cook gastrointestinal device. For any ophthalmic cystotome, single-use or reusable status comes from that manufacturer’s own instructions for use, not from the regulation.
The cystotome is one entry in a long list of instruments grouped under the same regulation; see ophthalmic surgical instruments for the wider group and Vannas scissors for another delicate instrument from that family. For how FDA reporting duties attach to devices once they are in use, see Medical Device Reporting (MDR), and for the regulator itself, FDA (Food and Drug Administration).
Common misunderstandings
“Class I means no regulation.”
Class I devices are subject to general controls. The 886.4350 exemption applies specifically to premarket notification, subject to the limitations in 886.9.
“A cystotome is the same as capsulorhexis forceps.”
They are different instruments. The BU primer describes the cystotome as the sharp-tipped puncturing instrument and Utrata-style forceps as the common second instrument, with a sharp-tipped forceps variant that some surgeons use instead.
“Every cystotome is a surgical needle.”
The ophthalmic cystotome can be needle-based, per the BU primer, but the name is also used for a 190 cm electrosurgical device in gastroenterology.
FAQ
What does cystotome mean?
In ophthalmology it is a manual, handheld surgical instrument named in 21 CFR 886.4350. It is a clinician’s instrument; this page gives no instructions for its use.
How does FDA classify a cystotome?
The ophthalmic cystotome is Class I under 21 CFR 886.4350, product code HNY, and is exempt from premarket notification subject to the limitations in 21 CFR 886.9 (eCFR and openFDA, checked 2026-10-31).
Is a cystotome the same as a needle?
Not always. A needle-based cystotome can be pre-bent according to the BU primer, but the regulation defines the generic type as a nonpowered, handheld ophthalmic surgical instrument without specifying a needle.
Can a cystotome refer to a non-eye device?
Yes. A Cook Medical gastrointestinal cystotome is listed as an electrosurgical, single-use device for pancreatic pseudocyst access, a different product from the ophthalmic instrument.
Sources
All sources checked 2026-10-31.
- eCFR, 21 CFR 886.4350, Manual ophthalmic surgical instrument: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-886/subpart-E/section-886.4350
- openFDA device classification, product code HNY: https://api.fda.gov/device/classification.json?search=product_code:HNY
- Boston University Eye Associates, Phaco Primer, Capsulorrhexis (educational page): https://www.bu.edu/eye/phacoprimer/capsulorrhexis/
- Cook Medical Cystotome 190 cm, CST-10 product listing (HealthManagement.org): https://healthmanagement.org/products/cystotome-190-cm-cst-10-cook-medical
