Utility Scissors Disposable Items
FDA 510(k) K843075 · Greene International Corp.
510(k) numberK843075
Submission
- Device name
- Utility Scissors Disposable Items
- Applicant
- Greene International Corp.
Mchenry, IL, US - Received
- August 6, 1984
- Decision date
- September 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOK – Scissors, Medical, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6820
- Specialty
- General Hospital
Other 510(k)s with product code JOK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K855131 | Suture Removal KitJOK · Traditional | Dynarex Corp. | 01/13/1986SE |
| 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 |
More from Superior Plastic Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K883827 | Masks, Various Types of Surgical MasksFXX · Traditional | 11/17/1988SE |
| K883828 | Cone Masks, Various Types of Surgical Cone MasksFXX · Traditional | 10/03/1988SE |
| K880484 | Surgical GarmentsFYC · Traditional | 06/27/1988SE |
| K870617 | Various Tyes of Surgical GarmentsFYF · Traditional | 03/09/1987SE |
| K843073 | Fixed Vol. Dispensers, Adjust Vol-HunpipJQW · Traditional | 08/24/1984SE |
| K843074 | Dispos. & Sponge Forceps Pean ArteryGEN · Traditional | 08/17/1984SE |
| K842719 | Standard WheelchairIQC · Traditional | 07/25/1984SE |
Questions and answers
When was Utility Scissors Disposable Items cleared by the FDA?
Utility Scissors Disposable Items (K843075) received a 510(k) decision of Substantially Equivalent on September 5, 1984, 30 days after the submission was received.
What is the product code of K843075?
The FDA product code is JOK – Scissors, Medical, Disposable, a Class I (low risk) device regulated under 21 CFR 880.6820.