# K952151: Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar Cords (D8202, D8204)

- Pathway: 510(k) (Traditional)
- Applicant: Storz
- Decided: Mar 4, 1996 after 301 days
- Product code: HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kirwan Ophthalmic Bipolar Forceps, Bipolar Pencils, and Bipolar Cord: named in the summary without a submission number
- (no number) Mentor WET-FIELD Bipolar Forceps and Bipolar Hemostatic Erasers: named in the summary without a submission number

## 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

## Indications for use
The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.

Source page: https://510kreport.com/device/K952151
Methodology: https://510kreport.com/methodology