# K212643: POWERSEAL Curved Jaw Sealer and Divider, Double Action

- Pathway: 510(k) (Special)
- Applicant: Olympus Surgical Technologies America
- Decided: Sep 27, 2021 after 38 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K932293 (1994). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203682: Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action, Olympus Winter & Ibe GmbH (2021) Summary page 4.

## Most influential descendants
- K231327: POWERSEAL Sealer and Divider (2023), 0 descendants of its own

## Recalls of this device
- Aug 18, 2026 · Class II · Z-3035-2026: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
- Mar 7, 2024 · Class II · Z-1699-2024: Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy woul
- Mar 7, 2024 · Class II · Z-1700-2024: Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy woul
- Mar 7, 2024 · Class II · Z-1701-2024: Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy woul
- Aug 12, 2022 · Class II · Z-1813-2022: An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
- Aug 12, 2022 · Class II · Z-1815-2022: An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
- Aug 12, 2022 · Class II · Z-1814-2022: An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

## Indications for use
The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy. The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.

Source page: https://510kreport.com/device/K212643
Methodology: https://510kreport.com/methodology