Skip to content

Presto Breast Biopsy Device

by Sontina Medical, LLC 2 variants

510(k) K120440

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120440 Date17 May 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Presto Breast Biopsy Device is a medical device indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The device was evaluated in non-clinical studies including in-vitro device performance, electrical and product safety (IEC 60601-1), tensile strength and fatigue, biocompatibility, predicate device comparison, and simulated use testing. It received FDA 510(k) clearance under K120440 and is manufactured by Sontina Medical, LLC.

Other devices from Sontina Medical, LLC

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Presto Breast Biopsy Device used for?

    The Presto Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to obtain tissue for histologic examination, allowing for partial or complete removal of the imaged abnormality to support pathological evaluation.

  • How is the Presto Breast Biopsy Device supplied and is it sterile?

    The device data does not specify whether the Presto Breast Biopsy Device is supplied sterile or non-sterile, nor does it detail its packaging or supply format. Information about sterility, single-use status, or supply configuration is not included in the provided device data and must be obtained from the manufacturer’s labeling or instructions for use.

  • What regulatory pathway was used for the Presto Breast Biopsy Device?

    The Presto Breast Biopsy Device received FDA 510(k) clearance under submission number K120440, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance pathway is based on demonstrating safety and effectiveness through comparison to a predicate, not through clinical trials alone.