Scissors, Medical, Disposable
FDA product code JOK · Class I (low risk) · 21 CFR 880.6820 · General Hospital
7510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K855131 | Suture Removal KitJOK · Traditional | Dynarex Corp. | 01/13/1986SE |
| K843075 | Utility Scissors Disposable ItemsJOK · Traditional | Greene International Corp. | 09/05/1984SE |
| K812555 | Disposable Suture Removal ScissorsJOK · Traditional | Medcare Products | 11/16/1981SE |
| K770595 | Suture Removal SetJOK · Traditional | Abco Dealers, Inc. | 05/23/1977SE |
| K770481 | Shear, Plastic Handle Utility S-475-7JOK · Traditional | Acme United Corp. | 04/29/1977SE |
| K770163 | Suture CutterJOK · Traditional | Concept, Inc. | 03/30/1977SE |
| K761192 | Dressing Change KitJOK · Traditional | Superior Plastic Products Corp. | 02/28/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2024-2024 Class II | MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (individual…There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors | MEDLINE INDUSTRIES, LP - Northfield | 04/30/2024Open, Classified |
| Z-1449-2024 Class II | Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-2595-2023 Class II | MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ040494.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector… | MEDLINE INDUSTRIES, LP - Northfield | 08/03/2023Open, Classified |