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Scion Medical Technologies, LLC

FDA Regulatory Profile

Scion Medical Technologies, LLC has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 27, 2012 · NAI
Latest 510(k)
Apr 27, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 27, 2012Kyle, TXDevicesNo Action Indicated (NAI)3009545273

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K170905Star Tissue MarkerApr 27, 2017
K161234CASSI II Rotational Core Biopsy SystemAug 3, 2016
K153189Beacon Tissue Marker (SE)Dec 17, 2015
K140835GENERAL AND PLASTIC SURGERYMay 20, 2014
K130763BEACON TISSUE MARKERMay 8, 2013
K123606CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLEMar 1, 2013

FDA data resources