# K912492: Evacuation/Irrigation/Elecrosurgical Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Oct 21, 1991 after 139 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K160128: Endopath Electrosurgery Probe Plus II (2016), 2 descendants of its own
- K082955: Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505 (2009), 2 descendants of its own
- K971146: Laparette (1997), 1 descendant of its own
- K250400: Vigeon Laparoscopic Universal Smoke Evacuator (VG003) (2025), 0 descendants of its own
- K180031: Endopath Electrosurgery Probe Plus II (2018), 0 descendants of its own

## Recalls of this device
- Apr 8, 2013 · Class II · Z-1772-2013: The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.
- Dec 9, 2008 · Not classified · Z-0655-2009: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those w
- Dec 9, 2008 · Not classified · Z-0656-2009: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those w
- Dec 9, 2008 · Not classified · Z-0659-2009: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those w
- Dec 9, 2008 · Not classified · Z-0660-2009: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those w
- Dec 9, 2008 · Not classified · Z-0657-2009: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those w
- Dec 9, 2008 · Not classified · Z-0658-2009: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those w
- Dec 9, 2008 · Not classified · Z-0661-2009: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those w
- Dec 9, 2008 · Not classified · Z-0662-2009: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those w
- Dec 9, 2008 · Not classified · Z-0663-2009: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those w
- Apr 20, 2006 · Not classified · Z-0917-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0924-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0925-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0926-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0921-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0919-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0920-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0915-06: There is the possibility of a seal void in the Probe Plus packaging which may compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0916-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0918-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0922-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
- Apr 20, 2006 · Not classified · Z-0923-06: There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.

Source page: https://510kreport.com/device/K912492
Methodology: https://510kreport.com/methodology