# K983569: Ksea Monopolar Vaporization Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jan 8, 1999 after 87 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Jun 1, 2009 · Class II · Z-1314-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1315-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1308-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1316-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1307-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1313-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1312-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1309-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1311-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1305-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1306-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
- Jun 1, 2009 · Class II · Z-1310-2013: Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

## Indications for use
These instruments are intended for use by qualified surgeons during Ob/Gyn hysteroscopic surgical procedures including: abnormal uterine bleeding, infertility, transuterine resection of fibroids, endometrial ablation, resectoscopic management of Mullerian fusion defects, resectoscopic management of intrauterine lesions, and resectoscopic management of intractable uterine bleeding.

Source page: https://510kreport.com/device/K983569
Methodology: https://510kreport.com/methodology