Home / Companies / Gi Scientific, LLC

Gi Scientific, LLC

FDA Regulatory Profile

Gi Scientific, LLC has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 30, 2023 · NAI
Latest 510(k)
Oct 8, 2019

Reviewing Gi Scientific, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Gi Scientific, LLC's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 30, 2023Mc Lean, VADevicesNo Action Indicated (NAI)3011178147
Dec 10, 2019Mc Lean, VADevicesNo Action Indicated (NAI)3011178147

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
K183171ScopeSeal Duodenoscope Protective DeviceOct 8, 2019
K140295GIS ENDOSCOPIC OPTICAL LENSJul 24, 2014

FDA data resources