# NLM: Laparoscope, General & Plastic Surgery, Reprocessed

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 23
- Recalls: 12 (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)
- 2007: 4
- 2010: 1
- 2011: 1
- 2012: 1
- 2013: 1
- 2014: 1
- 2016: 2
- 2017: 2
- 2019: 1
- 2020: 1

## Most-cited predicates
- K062497: Reprocessed Trocars (2007), cited by 2
- K070059: Reprocessed Trocars (2007), cited by 1
- K043592: Reprocessed Endoscopic Trocar (2005), cited by 1
- K043594: Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories (2005), cited by 1
- K043253: Vanguard Reprocessed Dilating Tip and Blunt Trocars (2005), cited by 1

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