Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
A cystoscopy drape is a sterile, single-use sheet that covers the patient around the perineum during a cystoscopy, with an opening (fenestration) through which the urological site is reached. In U.S. regulation it is not a separate device type: it falls under the FDA product code for disposable urological drapes, Class II and exempt from premarket notification. Clinic staff, buyers and students use this page to tell what the product is, how it is classified and what a product listing should state.
What a cystoscopy drape is
A cystoscopy drape is a surgical drape used for cystoscopy, the endoscopic examination of the urinary bladder. Under 21 CFR 878.4370, a surgical drape is a device made of natural or synthetic materials intended as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is a barrier between the patient and the surrounding area. It is not the scope, the tubing or the irrigation set.
Who uses it: urology clinics, endoscopy suites and operating rooms that perform cystoscopy, and the staff who stock and purchase their drapes and procedure packs.
How it is built
An example retailer listing for a sterile cystoscopy T drape (checked 2026-10-31; a product listing, not manufacturer instructions for use) describes these features:
- a T-shaped sheet with a perineal fenestration measuring 3 in by 6 in, and a 10 in by 10 in screen;
- a fluid-resistant, tear-resistant, low-lint fabric with reinforcement for fluid run-off;
- cord and tube holders;
- sterile and single use.
Other makers build drapes differently, so check each product’s own labeling rather than assuming these features.
Types and variants
| Type | Description | Source |
|---|---|---|
| Disposable urological drape | Named in 21 CFR 878.4370(b) as a Class II device exempt from premarket notification; FDA product code EYY, “Drape, Urological, Disposable”. | 21 CFR 878.4370; FDA classification database |
| Latex sheet drape with self-retaining finger cot | A drape intended to allow repeated insertion of the surgeon’s finger into the rectum during transurethral prostatectomy. It is a different product from a cystoscopy drape, listed under the same regulation. | 21 CFR 878.4370(a) |
| Cystoscopy T drape (example listing) | T-shaped, with perineal fenestration and screen, sterile, single use; sold by the case (16 drapes) in the example listing. | Retailer listing, 2026-10-31 |
Cystoscopy drapes are also supplied as a component of procedure packs. See the guide to the surgical pack for how packs are assembled, and what a sterile drape is for drapes in general.
How FDA classifies it
FDA’s product classification database lists code EYY, device name “Drape, Urological, Disposable”, under regulation number 878.4370 (Surgical drape and drape accessories), device class 2. Under 21 CFR 878.4370(b), a disposable urological drape is exempt from the premarket notification (510(k)) procedures in subpart E of part 807, subject to the limitations in 21 CFR 878.9. The regulation was issued at 53 FR 23872 (June 24, 1988) and amended at 84 FR 71814 (December 30, 2019). Exempt from 510(k) does not mean unregulated: the device is still a Class II medical device. For the wider framework, see FDA medical device classification, 510(k) and PMA.
What to read on a product listing
| Listing detail | Detail | Source |
|---|---|---|
| Sterile, single use | The example listing states both. | Retailer listing, 2026-10-31 |
| Fenestration size and screen | The example gives a 3 in by 6 in perineal fenestration and a 10 in by 10 in screen. | Retailer listing, 2026-10-31 |
| Fabric and fluid handling | The example lists strikethrough-resistant and tear-resistant fabric, low lint and fluid run-off reinforcement. | Retailer listing, 2026-10-31 |
| Regulatory identity | Disposable urological drapes are product code EYY, regulation 878.4370, Class II. | FDA database; 21 CFR 878.4370 |
Overall drape dimensions vary by product and are not tabulated here; use the size stated on the product label.
Safe use and handling basics
The regulation describes the drape’s role as a protective covering that helps isolate the site from microbial and other contamination. A product marked sterile and single use is meant to be used once; follow the manufacturer’s instructions for use for each product. This page gives no procedural steps; those belong to the facility’s protocols and the clinician performing the procedure.
Common points of confusion
- Drape versus tubing or scope. The drape covers the patient. Fluid lines are covered in what cystoscopy tubing is and the instrument in cystoscope parts.
- Exempt from 510(k) read as unregulated. The regulation classifies disposable urological drapes as Class II; the exemption removes only the premarket notification step, subject to 21 CFR 878.9.
- Treating one listing’s dimensions as a standard. Sizes are product-specific, so check the label.
FAQ
What is a cystoscopy drape?
A sterile, single-use surgical drape with a perineal opening, used to cover the patient for cystoscopy. FDA files disposable urological drapes under product code EYY.
Is a cystoscopy drape a medical device?
Yes. It falls under 21 CFR 878.4370 as a surgical drape, Class II, and disposable urological drapes are exempt from 510(k) notification.
What is the difference between a cystoscopy drape and a surgical pack?
The drape is one product; a pack is an assembled set that may include drapes. Contents differ by product, so read the pack’s contents list. See the urology clinic supply checklist for related supplies.
Sources
- FDA, Product Classification database, product code EYY: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=EYY (checked 2026-10-31); openFDA device classification API, same code: https://api.fda.gov/device/classification.json?search=product_code:EYY (checked 2026-10-31).
- 21 CFR 878.4370, Surgical drape and drape accessories: https://www.law.cornell.edu/cfr/text/21/878.4370 (checked 2026-10-31).
- Example retailer listing, cystoscopy T drape (not manufacturer instructions for use): https://markdown.wellbefore.com/products/cystoscopy-t-drape-sterile-62-w-x-40-w-x-100-l (checked 2026-10-31).
