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15mm Siteselect Breast Biopsy Device, 10 Mm Siteselect Breast Biopsy Device, 5mm Siteselect Breast Biopsy Device

by Imagyn Surgical

510(k) K993936

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 NumberK993936 Date27 Dec 1999ClearedStatusActive

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  • Withdrawn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 SiteSelect Breast Biopsy Device is a disposable, single-use diagnostic device used to obtain localized large core biopsies of breast tissue from a mammographic abnormality identified by the placement of a needle or localization wire. It is intended to provide tissue for histological examination with partial or complete removal of imaged lesions.

The device is supplied sterile and intended for single use only. It received FDA 510(k) clearance under K993936 as substantially equivalent, with product code KNW and regulation number 876.1075, and is classified under medical specialty Gastroenterology, Urology.

Other devices from Imagyn Surgical

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 SiteSelect Breast Biopsy Device used for?

    It is used to obtain localized large core biopsies of breast tissue from a mammographic abnormality identified by needle or localization wire placement, providing tissue for histological examination with partial or complete removal of imaged lesions.

  • Is the SiteSelect Breast Biopsy Device sterile and single-use?

    Yes, the device is supplied sterile and intended for single use only, as stated in the device description, to ensure patient safety and prevent cross-contamination during biopsy procedures.

  • What sizes are available for the SiteSelect Breast Biopsy Device?

    The device is available in three sizes: 5MM, 10MM, and 15MM, as indicated in the product name, allowing clinicians to select the appropriate size based on lesion characteristics and biopsy requirements.

  • How was the SiteSelect Breast Biopsy Device cleared for market?

    It received FDA 510(k) clearance under K993936 as substantially equivalent to a predicate device, with product code KNW and regulation number 876.1075, based on a traditional review process completed in December 1999.