Shear, Plastic Handle Utility S-475-7
FDA 510(k) K770481 · Acme United Corp.
510(k) numberK770481
Submission
- Device name
- Shear, Plastic Handle Utility S-475-7
- Applicant
- Acme United Corp.
Mchenry, IL, US - Received
- March 11, 1977
- Decision date
- April 29, 1977
- 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 |
| K812555 | Disposable Suture Removal ScissorsJOK · Traditional | Medcare Products | 11/16/1981SE |
| K770595 | Suture Removal SetJOK · Traditional | Abco Dealers, Inc. | 05/23/1977SE |
| 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 |
|---|---|---|
| K961323 | Lyofoam Extra C Odor Absorbing Wound DressingKMF · Traditional | 06/19/1996SE |
| K961452 | Lyofoam Extra 'A' Sterile Adhesive Wound DressingKMF · Traditional | 05/31/1996SE |
| K952565 | Lyofoam ExtraKMF · Traditional | 11/14/1995SN |
| K895764 | Modified Lyofoam Wound DressingsKMF · Traditional | 09/10/1990SN |
| K871740 | Lyosheet Surgical Sheet for BurnsFPY · Traditional | 06/09/1987SE |
| K864084 | Lyofoam C Odor-Absorbing DressingFRO · Traditional | 11/21/1986SN |
| K860085 | Lyofoam Wound DressingsNAD · Traditional | 06/27/1986SN |
| K860818 | One Time Enteral Feeding BagKNT · Traditional | 05/15/1986SE |
| K861015 | One Time Hyperal & Catheter Dressing Change TraysFOZ · Traditional | 04/22/1986SE |
| K842186 | Acu-Derm Transparent Wound DressingNAD · Traditional | 08/24/1984SE |
Questions and answers
When was Shear, Plastic Handle Utility S-475-7 cleared by the FDA?
Shear, Plastic Handle Utility S-475-7 (K770481) received a 510(k) decision of Substantially Equivalent on April 29, 1977, 49 days after the submission was received.
What is the product code of K770481?
The FDA product code is JOK – Scissors, Medical, Disposable, a Class I (low risk) device regulated under 21 CFR 880.6820.