# K955168: Surgical Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Promex, Inc.
- Decided: Jan 22, 1996 after 70 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K161307: NICO Myriad (2016), 4 descendants of its own
- K182340: NICO Myriad (2018), 1 descendant of its own
- K180372: Aurora Evacuator (2018), 1 descendant of its own
- K191599: NICO Myriad NOVUS (2019), 0 descendants of its own
- K190075: Aurora Evacuator (2019), 0 descendants of its own

## Recalls of this device
- Jul 29, 2015 · Class II · Z-2767-2015: Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connector
- Feb 24, 2014 · Class II · Z-2045-2016: This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rend

Source page: https://510kreport.com/device/K955168
Methodology: https://510kreport.com/methodology