# HAM: Apparatus, Electrosurgical

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 31
- Recalls: 3 (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)
- 1987: 1
- 1988: 5
- 1989: 4
- 1990: 1
- 1991: 1
- 1992: 2
- 1995: 1
- 1999: 1
- 2000: 1
- 2016: 1

## Most-cited predicates
- K000079: Nikopad Electrosurgical Grounding Pad, Model 4777M (2000), cited by 3
- K871435: Bard Ems System 6000 E.S.U. (1987), cited by 1
- K894762: B100 Disposable Handpiece (1989), cited by 1
- K810909: Micro Cautery (1981), cited by 1
- K945861: Bergen 710 Esu (1995), cited by 1
- K993306: Nikopad Electrosurgical Grounding Pad (*or Sold Under Commercial Names), Model 4760 (Typically) (1999), cited by 1
- K884172: Modified Olsen #770 Disposable Holster (1988), cited by 1
- K853291: GP-100 Adult Electrosurgical Ground Pad/200 & 300 (1985), cited by 1

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