# K100520: Nipro Biohole Needle with Capick Scab Remover

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corporation
- Decided: Mar 17, 2010 after 22 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Medisystems ButtonHole Needle with SteriPick: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K060383: Glucose, Abbott Laboratories (2006). Our reading of the summary gave K060383, FDA’s number for Glucose (Abbott Laboratories). Its FDA name has none of the distinctive words the summary uses for the device it names, “NIPRO BioHole Needle”. Kept off the family tree. Summary page 1.

## Indications for use
The NIPRO BioHole Needle with CAPICK Scab Remover is intended for use as a blood access device for dialysis procedures using a constant-site cannulation technique of needle insertion with an established, mature constant-site also known as a buttonhole access site.

Source page: https://510kreport.com/device/K100520
Methodology: https://510kreport.com/methodology