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510(k) K213627

RF Vapor System by Aqua Medical, Inc. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2021
Date Received
November 17, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Aqua Medical, Inc.

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  • K211282 — Aqua Medical RF Vapor System (May 27, 2021)
  • K183595 — Aqua Medical RF Vapor System (June 21, 2019)

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