# K110924: Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: Dec 7, 2011 after 247 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K884656 (1988). 3 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080187: Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps, Olsen Medical (2008) Summary page 1.

## Most influential descendants
- K121426: Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps (2012), 7 descendants of its own
- K162469: CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps (2016), 2 descendants of its own
- K193587: Sutter Swyng non-stick bipolar forceps, single-use (2020), 1 descendant of its own
- K160103: Spetzler Malis Dual Illuminating Bipolar Forceps (2016), 1 descendant of its own
- K123172: Kogent Bipolar Forceps (2012), 1 descendant of its own

## Recalls of this device
- Sep 11, 2023 · Class II · Z-0247-2024: An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf li
- Sep 11, 2023 · Class II · Z-0257-2024: An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf li
- Sep 11, 2023 · Class II · Z-0239-2024: An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf li

## Indications for use
The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.

Source page: https://510kreport.com/device/K110924
Methodology: https://510kreport.com/methodology