Stocking, Elastic
FDA product code ILG · Class I (low risk) · 21 CFR 890.3475 · Physical Medicine
8510(k) clearances
0PMA approvals
3recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K833437 | Orthopedic StockinetteILG · Traditional | Northern Medical Surgical, Inc. | 11/03/1983SE |
| K831540 | Compressogrip Elastic Stump Shrinker#ILG · Traditional | Fred Sammons, Inc. | 06/08/1983SE |
| K780612 | Stockinette, SterileILG · Traditional | Abco Dealers, Inc. | 04/19/1978SE |
| K780547 | Sterile Orthopedic StockinetteILG · Traditional | Alba-Waldensian, Inc. | 04/10/1978SE |
| K770346 | Orthopedic StockinetteILG · Traditional | Convertors | 03/07/1977SE |
| K770173 | StockinetteILG · Traditional | Chase Mfg. Co. | 02/08/1977SE |
| K760817 | Orthopedic Tubular StockinetteILG · Traditional | Parke-Davis Co. | 10/20/1976SE |
| K760576 | Tourniwrap BandageILG · Traditional | Richard'S Medical Equip., Inc. | 10/05/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1302-2021 Class II | In-View Clear Leggings Bulk Non-SterileCardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these… | Cardinal Health 200, LLC | 02/25/2021Terminated |
| Z-1301-2021 Class II | In-View Clear Leggings Sterile Non-SterileCardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these… | Cardinal Health 200, LLC | 02/25/2021Terminated |
| Z-1300-2021 Class II | In-View Clear Leggings SterileCardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these… | Cardinal Health 200, LLC | 02/25/2021Terminated |