# OCW: Endoscopic Tissue Approximation Device

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 71
- 510(k) review time 2021–2025: median 133 days (middle half 82–289)
- Recalls: 4 (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)
- 2013: 2
- 2016: 2
- 2017: 2
- 2018: 2
- 2019: 1
- 2020: 1
- 2021: 3
- 2023: 3
- 2025: 1
- 2026: 2

## Most-cited predicates
- K070686: Mini Lap Instruments (2007), cited by 6
- K002398: Endopath ETS45, Ets FLEX45, Ets Compact-FLEX45 Linear Cutters, Ets FLEX45 and Ets Compact-FLEX45 NO-Knife Articulating (2000), cited by 6
- K062875: Endogastric Stomaphyx Device and Accessories (2007), cited by 6
- K090470: Autosuture Protack; Tacker System; Absorbatack Fixation Devices (2009), cited by 6
- K961390: Endopath Ets Linear/Ets-Flex Articulating Linear Endoscopic Cutter (1996), cited by 5
- K934738: Autosuture Endoscopic Suturing Device (1994), cited by 4
- K132362: Weck Efx Endo Fascial Closure System (2013), cited by 4
- K970720: Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife Endoscopic Linear Stapler (1997), cited by 3
- K944415: Origin Tacker System (1994), cited by 3
- K171886: OverStitch SX Endoscopic Suturing System (ESS) (2017), cited by 3

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