# K965245: TBD

- Pathway: 510(k) (Traditional)
- Applicant: Utah Medical Products, Inc.
- Decided: Jul 3, 1997 after 184 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- 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 K922002 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955093: Aspiration/Coagulation Electrode Ace-311 & Ace-511, Utah Medical Products, Inc. (1996) Summary page 1.
- K922002: Suction Irrigation Cautery Probe, Megadyne Medical Products, Inc. (1992) Summary page 1.

## Indications for use
The Irrigation/Aspiration/Coagulation Electrodes, ICE-311 and ICE-511, are indicated for electrosurgical fulguration (coagulation) of the uterine cervix as part of the procedure called Loop Excision of the Transformation Zone (LETZ®), or other loop electrosurgery procedures where simultaneous electrosurgical fulguration and small-volume fluid irrigation and/or aspiration is needed.

Source page: https://510kreport.com/device/K965245
Methodology: https://510kreport.com/methodology