# HOZ: Sponge, Ophthalmic

- Device class: 2; regulation: 21 CFR 886.4790; FDA's rule: 510(k) exempt
- FDA decisions: 47
- Recalls: 8 (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)
- 1994: 1
- 1995: 2
- 1997: 4
- 1998: 1
- 1999: 4
- 2000: 1
- 2001: 3
- 2008: 1
- 2009: 1
- 2013: 2

## Most-cited predicates
- K923922: Surgical Spears (1993), cited by 2
- K990671: Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument Wipe (1999), cited by 1
- K780987: Soft Silicone Elastomer Sponge Explant (1978), cited by 1
- K972693: Deroyal Industries, Inc. Surgical Eye Spear (1997), cited by 1
- K002279: ML Eye Spear, Model ML 27 ES (2000), cited by 1
- K920354: Ophthalmic Sponges (1992), cited by 1

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