Disposable Suture Removal Scissors
FDA 510(k) K812555 · Medcare Products
510(k) numberK812555
Submission
- Device name
- Disposable Suture Removal Scissors
- Applicant
- Medcare Products
Mchenry, IL, US - Received
- September 8, 1981
- Decision date
- November 16, 1981
- 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 |
| K843075 | Utility Scissors Disposable ItemsJOK · Traditional | Greene International Corp. | 09/05/1984SE |
| 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 |
|---|---|---|
| K841122 | Tracheostomy Care TrayFSM · Traditional | 04/25/1984SE |
| K841124 | Dialysis TrayKOC · Traditional | 04/20/1984SE |
| K841123 | Dressing Change TrayFRG · Traditional | 04/17/1984SE |
| K831374 | Med Care Prep Razor · Traditional | 10/04/1983SE |
| K831663 | Tissue ForcepsKOC · Traditional | 09/26/1983SE |
| K831665 | Disposable Needle HolderKDC · Traditional | 09/12/1983SE |
| K831664 | Plastic Thumb ForcepsKDC · Traditional | 09/12/1983SE |
| K831661 | Disposable ScissorsKDC · Traditional | 08/25/1983SE |
| K831662 | Disposable Hemostat (Straight&CurvedKDC · Traditional | 07/19/1983SE |
| K823854 | Medcare Suture Removal TraysFSM · Traditional | 03/31/1983SE |
Questions and answers
When was Disposable Suture Removal Scissors cleared by the FDA?
Disposable Suture Removal Scissors (K812555) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 69 days after the submission was received.
What is the product code of K812555?
The FDA product code is JOK – Scissors, Medical, Disposable, a Class I (low risk) device regulated under 21 CFR 880.6820.