# K003587: Clearglide Precision Bipolar Device

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 4, 2000 after 13 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 10 (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; 3 cite 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K024304: Microsurgical Bipolar Handpiece (2003), 2 descendants of its own
- K040584: NMX-1000 (2004), 1 descendant of its own
- K220891: Kahook Dual Blade Glide (KDB Glide) (2024), 0 descendants of its own
- K102983: Vascuclear Precision Bipolar (2010), 0 descendants of its own
- K012033: Multifunction Endoscopic Instrument (2001), 0 descendants of its own

## Recalls of this device
- Nov 25, 2009 · Not classified · Z-0625-2010: Vessel clamping device may break during use.
- Nov 25, 2009 · Not classified · Z-0624-2010: Vessel clamping device may break during use.
- Nov 25, 2009 · Not classified · Z-0630-2010: Vessel clamping device may break during use.
- Nov 25, 2009 · Not classified · Z-0628-2010: Vessel clamping device may break during use.
- Nov 25, 2009 · Not classified · Z-0626-2010: Vessel clamping device may break during use.
- Nov 25, 2009 · Not classified · Z-0627-2010: Vessel clamping device may break during use.
- Nov 25, 2009 · Not classified · Z-0629-2010: Vessel clamping device may break during use.
- May 7, 2007 · Not classified · Z-1156-2007: Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, par
- May 7, 2007 · Not classified · Z-1158-2007: Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, par
- May 7, 2007 · Not classified · Z-1157-2007: Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, par

Source page: https://510kreport.com/device/K003587
Methodology: https://510kreport.com/methodology