# K121426: Aynergetics Disposable Spetzler-Malis Standard Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: Jul 10, 2012 after 57 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K884656 (1988). 4 ancestors in all.
7 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)
- K110924: Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps, Synergetics, Inc. (2011) Summary page 1.

## Most influential descendants
- 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
- K232703: Disposable Bipolar Forceps (2024), 0 descendants of its own

## Recalls of this device
- Sep 11, 2023 · Class II · Z-0243-2024: 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-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-0248-2024: 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-0249-2024: 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-0250-2024: 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-0253-2024: 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-0256-2024: 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-0241-2024: 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-0244-2024: 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-0251-2024: 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-0255-2024: 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
- Sep 11, 2023 · Class II · Z-0240-2024: 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-0242-2024: 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-0245-2024: 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-0246-2024: 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-0252-2024: 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-0254-2024: 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 Speztler-Malis Standard Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

Source page: https://510kreport.com/device/K121426
Methodology: https://510kreport.com/methodology