What Is an Anoscope? Definition, Size and Anoscope vs Proctoscope

General product and regulatory information for lab, clinic and supply staff. It is not medical advice and does not describe how to perform any procedure.

Short answer

An anoscope is a short, rigid, hollow instrument used to look into the anus and lower anal canal. In FDA’s product classification it is “Anoscope and accessories” (product code FER), a Class 2 device regulated under 21 CFR 876.1500 with the stated use “to examine and perform procedures within the anus and rectum.” A proctoscope is the longer related instrument that reaches the rectum.

Definition and scope

Cleveland Clinic describes an anoscope as a rigid, hollow instrument, and notes it is also called an anal speculum. The examination it supports is called anoscopy: the instrument is the anoscope, the examination is the anoscopy. Searches for “anoscope” therefore mix people looking for the device with people looking for the exam.

For equipment and supply staff, the useful scope is the device itself. FDA groups it with other endoscopic access devices: 21 CFR 876.1500 (Endoscope and accessories) covers devices used “to provide access, illumination, and allow observation or manipulation of body cavities,” and its examples include “nonpowered anoscopes” and “proctoscopes.” For the broader family of examination specula, see what a speculum is.

How an anoscope is used in practice

The anoscope is the instrument that gives a clinician a view of the anal canal during an anoscopy. Cleveland Clinic notes that models vary in shape (tapered, or straight-sided with a beveled tip) and that a pediatric anoscope used for children is smaller. How the examination is carried out belongs to trained clinicians and is outside the scope of this page.

Anoscope vs proctoscope

Both are rigid scopes, but they differ in how far they reach. Cleveland Clinic describes the anoscope as the shorter instrument, used mainly to view the anus, and the proctoscope as a longer scope used to visualize the rectum. FDA’s regulation names the two as separate examples under the same device regulation.

Point	Anoscope	Proctoscope	Source
Region viewed	Mainly the anus	The rectum	Cleveland Clinic
Relative length	Shorter	Longer	Cleveland Clinic
Named in 21 CFR 876.1500	Yes, as “nonpowered anoscopes”	Yes, as “proctoscopes”	21 CFR 876.1500

Anoscope size

Cleveland Clinic gives the typical size of the instrument as about 1 to 2 inches wide and 3 to 5 inches long. The FDA classification record and the regulation do not set a standard size chart for anoscopes, so dimensions are a property of each manufacturer’s product and its labeling. Treat any single published range as a general description, not a specification.

Anoscope designs and materials

Cleveland Clinic notes two common designs: some anoscopes are made of translucent plastic, while others are opaque with slotted sides. This describes appearance and material, not performance.

Is an anoscope disposable?

FDA lists “Anoscope and accessories” as a single device type and does not divide it into single-use and reusable products. Cleveland Clinic describes translucent plastic and opaque slotted designs without stating whether they are used once. Whether a particular model is single-use or reusable, and how a reusable one is to be reprocessed, is stated in that manufacturer’s instructions for use.

Regulatory classification and what it means for supply decisions

Facts from FDA’s Product Classification database (checked 2026-10-30):

Field	Entry for product code FER
Device name	Anoscope and accessories
Device class	2
Regulation number	876.1500
Definition	To examine and perform procedures within the anus and rectum
GMP exempt	No

Two practical readings follow, both tied to the record above. First, Class 2 means the device sits in FDA’s middle risk tier under the framework created by the Medical Device Amendments of 1976. Second, the “GMP exempt: No” entry means the quality system requirements are not waived for this product code. Manufacturer and user-facility reporting duties for device problems are covered under Medical Device Reporting. FDA also publishes recognized consensus standards that manufacturers may cite for devices; check a product’s own labeling for any it claims.

Labeling checklist for an anoscope listing

Size, material and reuse are set by the manufacturer, so these are the points a product’s own labeling or instructions for use would need to answer. The list is a reading aid, not a purchasing recommendation.

• Device name and intended use, compared with FDA’s “Anoscope and accessories” entry.
• Dimensions, since published typical sizes are general descriptions.
• Material and design (for example translucent plastic or opaque with slotted sides).
• Whether the product is labeled single-use or reusable.
• Whether the item is the instrument alone or includes accessories.

Common misunderstandings

• Anoscope and anoscopy are the same thing. The anoscope is the instrument; anoscopy is the examination.
• An anoscope reaches the whole rectum. Cleveland Clinic describes the anoscope as mainly viewing the anus; the longer proctoscope is the instrument described for the rectum.
• There is a single standard size. The regulation and classification record do not set one; sizes come from each product.

Frequently asked questions

What is the difference between an anoscope and a proctoscope?

An anoscope is the shorter instrument and is used mainly to view the anus; a proctoscope is longer and is used to visualize the rectum (Cleveland Clinic). Both are named in 21 CFR 876.1500.

What size is an anoscope?

Cleveland Clinic gives about 1 to 2 inches wide and 3 to 5 inches long. No FDA size standard is set, so a specific product’s labeling governs.

Is an anoscope disposable?

FDA does not define the category as single-use or reusable. Plastic and slotted designs both exist (Cleveland Clinic); the manufacturer’s instructions for use state a given model’s reuse status.

How does FDA classify an anoscope?

As “Anoscope and accessories,” product code FER, Class 2, regulation 876.1500, not exempt from GMP requirements (FDA Product Classification, checked 2026-10-30).

Sources

• U.S. Food and Drug Administration, Product Classification, code FER: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=FER. Checked 2026-10-30.
• 21 CFR 876.1500, Endoscope and accessories: https://www.law.cornell.edu/cfr/text/21/876.1500. Checked 2026-10-30.
• Cleveland Clinic, Anoscopy: https://my.clevelandclinic.org/health/treatments/24993-anoscopy. Checked 2026-10-30.