# K982142: Mountable Endoscopic Knife

- Pathway: 510(k) (Traditional)
- Applicant: A.M. Surgical, Inc.
- Decided: Dec 30, 1998 after 196 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080133: Mountable Endoscopic Blade (2008), 9 descendants of its own
- 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

## Indications for use
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Source page: https://510kreport.com/device/K982142
Methodology: https://510kreport.com/methodology