# HBO: Clip, Scalp

- Device class: 2; regulation: 21 CFR 882.4150; FDA's rule: 510(k) required
- FDA decisions: 11
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1988: 2
- 1989: 2
- 1990: 1
- 1991: 1
- 1994: 1
- 2001: 1
- 2004: 1
- 2005: 1
- 2026: 1

## Most-cited predicates
- K012219: Scalpfix Clip System (2001), cited by 2
- K905433: Codman Disposable Scalp Clip Applier (1991), cited by 1
- K944311: Acra-Cut (1994), cited by 1
- K896723: Clip Gun with Raney Type Scalp Clips (1990), cited by 1
- K890443: Caspar Scalp Clip, Applier (1989), cited by 1

Source page: https://510kreport.com/product-code/HBO
Data by year (CSV): https://510kreport.com/product-code/HBO.csv