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FDA 510(k)

POWERSEAL Curved Jaw Sealer and Divider, Double Action

K-Number: K212643 · 2021-09-27

ApplicantOlympus Surgical Technologies America
Decision Date2021-09-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POWERSEAL Curved Jaw Sealer and Divider, Double Action is a medical device manufactured by Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2021-09-27 under approval number K212643. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERSEAL Curved Jaw Sealer and Divider, Double Action?

POWERSEAL Curved Jaw Sealer and Divider, Double Action is a medical device that received FDA 510(k) clearance on 2021-09-27. It is manufactured by Olympus Surgical Technologies America. The 510(k) number is K212643.

When was POWERSEAL Curved Jaw Sealer and Divider, Double Action approved by the FDA?

POWERSEAL Curved Jaw Sealer and Divider, Double Action received FDA 510(k) clearance on 2021-09-27, under approval number K212643.

What company makes POWERSEAL Curved Jaw Sealer and Divider, Double Action?

POWERSEAL Curved Jaw Sealer and Divider, Double Action is manufactured by Olympus Surgical Technologies America.

What is the FDA product code for POWERSEAL Curved Jaw Sealer and Divider, Double Action?

The FDA product code for POWERSEAL Curved Jaw Sealer and Divider, Double Action is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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