# GCJ: Laparoscope, General & Plastic Surgery

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 1,431
- 510(k) review time 2021–2025: median 103 days (middle half 60–189)
- Recalls: 149 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 20
- 2018: 21
- 2019: 15
- 2020: 28
- 2021: 18
- 2022: 20
- 2023: 31
- 2024: 29
- 2025: 21
- 2026: 26

## Most-cited predicates
- K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar (2003), cited by 26
- K182606: PINPOINT Endoscopic Fluorescence Imaging System (2018), cited by 12
- K973700: Hermes Operating Room Control Center (1998), cited by 9
- K010007: Adapt Laparoscopic Port & Adapt Reducer Cap (2001), cited by 8
- K011016: Lsi Solutions Flexible Suture Placement Device and Accessories Product (2001), cited by 7
- K122511: Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath (2012), cited by 7
- K130435: Versaport V2 Bladeless Optical Trocar (2013), cited by 7
- K931783: Aesop (Automated Endoscopic System for Optimal Pos (1993), cited by 7
- K972699: Aesop 3000 System and Accessories (1997), cited by 7
- K112358: Unimax Trocar System (2011), cited by 6

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