# Insight Medical Corp.

- Location (FDA's records): Bolton, MA
- FDA decisions: 3 (1994–1998): 3 510(k) clearances
- Product codes: MNG (2), JXE (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K963858: Femassist Urinary Device (1997), cited by 1

## Recent decisions
- K974645: Femassist Flexible (Feb 12, 1998)
- K963858: Femassist Urinary Device (Oct 21, 1997)
- K932533: Smartscope (Mar 31, 1994)

Source page: https://510kreport.com/company/insight-medical