# K153055: ACE Electrosurgical Resection and Vaporization Electrodes Series

- Pathway: 510(k) (Traditional)
- Applicant: Ace Medical Devices Pvt., Ltd.
- Decided: Jul 11, 2016 after 265 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911904 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120418: Electrosugrical Resection and Vaporization Electrode Series, Olympus Winter & Ibe GmbH (2012) Summary page 5.

## Indications for use
The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and coagulation where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectomy (TURP), transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used to treat cancer of the prostate. The ACE Electrosurgical Resection and Vaporization Electrode Series are single use bipolar electrodes designed and intended for use in urological surgical procedures involving the vaporization, ablation, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH) bladder cancer, tumors, lesions, and neoplasms. The specific urological indications include transurethral electro vaporization (TUVP, TVP, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used in treating cancer of the prostate.

Source page: https://510kreport.com/device/K153055
Methodology: https://510kreport.com/methodology