GRI-Alleset, Inc.
Flowery Branch, GA, US
GRI-Alleset, Inc. appears in FDA device records in Flowery Branch, GA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for GRI-Alleset, Inc. between 2021 and 2024. The busiest year on record is 2022, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242664 | gentleheel® Adult Incision Device | FMK | Substantially Equivalent | |
| K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | FMK | Substantially Equivalent | |
| K210860 | Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 | FXX | Substantially Equivalent | |
| K210131 | ComfortGuard Surgical Isolation Gown | FYC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009203853 | 3009203853 | GRI-Alleset, Inc. | 4142 INDUSTRY WAY, Flowery Branch, GA 30542 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OFQAnesthesia Kit
- OEZCardiovascular Procedure Kit
- OHMCesarean Section Tray
- OXQDressing Change Tray
- OGREar, Nose, And Throat Surgical Tray
- LROGeneral Surgery Tray
- FYCGown, Isolation, Surgical
- MLSLabor And Delivery Kit
- FXXMask, Surgical
- PYBMinor Surgical Procedures Tray
- PWLOral Surgery Tray
- OJHOrthopedic Tray
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain