# HET: Laparoscope, Gynecologic (And Accessories)

- Device class: 2; regulation: 21 CFR 884.1720; FDA's rule: 510(k) required
- FDA decisions: 338
- 510(k) review time 2021–2025: median 189 days (middle half 165–269)
- Recalls: 16 (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)
- 2012: 2
- 2013: 2
- 2015: 2
- 2017: 2
- 2018: 1
- 2019: 2
- 2020: 2
- 2021: 4
- 2022: 1
- 2025: 2

## Most-cited predicates
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments (2005), cited by 7
- K963076: Laparoscopic Bone Anchored Urethropexy Instrument Tray (1997), cited by 6
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 (2013), cited by 6
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 (2012), cited by 6
- K111788: Endoeye HD II (2012), cited by 4
- K080948: HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH (2008), cited by 4
- K953574: Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer (1995), cited by 4
- K993801: Gynecare Laparoscopic Morcellator (2000), cited by 4
- K915857: Flexible Tip Thoracoscope/Laparoscope (1994), cited by 3
- K151011: Visera 4K Uhd System (2015), cited by 3

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