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This page describes products and general use; it is not medical advice.
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Who uses it: endoscopic biopsy forceps are clinical instruments used by clinicians; this page is for clinic staff, buyers and students who need to identify the product class and tell the cold and hot types apart.
What endoscopic biopsy forceps are
Endoscopic biopsy forceps are forceps used with an endoscope to collect a small tissue sample for microscopic examination. The FDA regulation that covers them, 21 CFR 876.1075, defines a gastroenterology-urology biopsy instrument as “a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination.” Its generic type explicitly lists nonelectric biopsy forceps. “Endoscopy forceps” is another name for the same product family. For the scope itself, see what an endoscope is.
How they are built
The FDA 510(k) summary for one cleared example, the Olympus Single Use Hot Biopsy Forceps FD-231 (K171916, cleared October 13, 2017), describes a handle and an insertion portion with fenestrated cups at the distal end. A slider on the handle opens and closes the cups. That example is single-use, ethylene oxide sterilized, with a validated three-year shelf life (ASTM F1980-16). It is one product, not a description of every forceps, and other makes differ.
Cold (non-electric) vs hot biopsy forceps
The key distinction is whether electrical current is involved. FDA classifies the two under different product codes and different regulations:
| Type | FDA product code and name | Regulation | Class | What the FDA record says |
|---|---|---|---|---|
| Cold (non-electric) | FCL, forceps, biopsy, non-electric | 21 CFR 876.1075 | Class I, 510(k) exempt | The manufacturer must still register its establishment. |
| Hot (electric) | KGE, forceps, biopsy, electric | 21 CFR 876.4300, endoscopic electrosurgical unit and accessories | Class II; GMP-exempt: No | In the K171916 example, high-frequency current is delivered through the cups and returns through a patient plate electrode; labelled for prescription use. |
The K171916 example is indicated for use with an Olympus endoscope to collect tissue electrosurgically, cauterize or perform hemostasis in urinary organs. For the electrosurgical side, see what an electrosurgical unit is.
How regulators classify them
Under 21 CFR 876.1075 the biopsy instrument category is generally Class II, but the nonelectric biopsy forceps and the biopsy forceps cover are Class I and exempt from 510(k), subject to the limits in 21 CFR 876.9. Electric forceps are not covered by that exemption: they sit under 21 CFR 876.4300 as Class II. This is why “hot biopsy forceps” is a different regulated product from ordinary biopsy forceps, not a variant of the same listing.
Safe use and handling basics
- Use a forceps only as its manufacturer’s instructions for use describe, with the endoscope and generator it names.
- Check the labelling for single-use or reusable status; the K171916 example is labelled single-use and sterilized before supply.
- Electric forceps are labelled for prescription use.
- For how endoscopes and accessories are reprocessed, see high-level disinfection and the Spaulding classification.
Common mistakes
- Treating hot and cold forceps as one product. They carry different FDA product codes (KGE and FCL) and different classes.
- Reading “510(k) exempt” as “unregulated”. FCL devices are Class I and the manufacturer must still register its establishment.
- Mixing up graspers and biopsy forceps. The regulation defines biopsy instruments by tissue sampling; graspers are a separate instrument name (see laparoscopic instruments).
FAQ
What are endoscopy forceps?
“Endoscopy forceps” is a general name for forceps used through an endoscope. Biopsy forceps are the tissue-sampling type, covered by 21 CFR 876.1075 when non-electric. A broader overview is in medical forceps types.
What are hot biopsy forceps?
Hot biopsy forceps pass high-frequency electrical current through the cups to collect tissue electrosurgically or cauterize. FDA lists them as product code KGE, Class II, under 21 CFR 876.4300.
How is an endoscopic grasper different from biopsy forceps?
The FDA regulation defines biopsy forceps by their purpose of removing a tissue specimen for microscopic examination. “Endoscopic grasper” is a separate instrument name and is not the product classified under 21 CFR 876.1075.
Sources
- eCFR, 21 CFR 876.1075 Gastroenterology-urology biopsy instrument: ecfr.gov (checked 2026-10-31)
- FDA product classification FCL: accessdata.fda.gov (checked 2026-10-31)
- FDA product classification KGE: accessdata.fda.gov (checked 2026-10-31)
- FDA 510(k) K171916 summary (PDF), Olympus Single Use Hot Biopsy Forceps FD-231: accessdata.fda.gov (checked 2026-10-31)
- FDA 510(k) database entry K171916: accessdata.fda.gov (checked 2026-10-31)
