# K012074: XBO1-824-18/19/20 Biopsy Forceps

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: Sep 25, 2001 after 85 days
- Product code: OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911448 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911448: Multiple Biopsy Device-MBX, Triton Technology, Inc. (1991) Summary page 5.
- K955065: Olympus FB Series Biopsy Forceps, Olympus America, Inc. (1996) Summary page 5.

## Indications for use
Olympus BIOPSY FORCEPS has been designed to be used with an Olympus endoscope to collect tissue samples within the upper and lower digestive tract and to extract the tissue samples though the biopsy forceps with suction.

Source page: https://510kreport.com/device/K012074
Methodology: https://510kreport.com/methodology