# K080133: Mountable Endoscopic Blade

- Pathway: 510(k) (Traditional)
- Applicant: A.M. Surgical, Inc.
- Decided: Mar 13, 2008 after 55 days
- Product code: EMF (Knife, Surgical)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982142 (1998). 1 ancestor in all.
9 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982142: Mountable Endoscopic Knife, A.M. Surgical, Inc. (1998) Summary page 2.

## Most influential descendants
- K181819: SMARTRELEASE Endoscopic Soft Tissue Release System (2018), 6 descendants of its own
- K223406: SmartRelease Endoscopic Soft Tissue Release System (2023), 2 descendants of its own
- K222490: HBL Blade Assembly (2022), 1 descendant of its own
- K252020: TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (2025), 0 descendants of its own
- K252594: UltraGuideCTR® image guided soft tissue release system (2025), 0 descendants of its own

## Indications for use
The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release. * Carpal tunnel release for carpal tunnel syndrome * Plantar fasciotomy for plantar fasciitis * Lateral release of the knee for extensor mechanism malalignment * Forearm fasciotomy for compartment syndrome * Morton's neuroma for interdigital neuroma * Gastrocnemius release for heel cord contracture (equinus)

Source page: https://510kreport.com/device/K080133
Methodology: https://510kreport.com/methodology