510(k) K231323

Ancora-SB by Aspero Medical, Inc. — Product Code FDA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 31, 2023
Date Received: May 8, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Enteroscope And Accessories
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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