Suture Cutter
FDA 510(k) K770163 · Concept, Inc.
510(k) numberK770163
Submission
- Device name
- Suture Cutter
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- January 25, 1977
- Decision date
- March 30, 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 |
| K770481 | Shear, Plastic Handle Utility S-475-7JOK · Traditional | Acme United Corp. | 04/29/1977SE |
| K761192 | Dressing Change KitJOK · Traditional | Superior Plastic Products Corp. | 02/28/1977SE |
More from Superior Plastic Products Corp.
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|---|---|---|
| K912640 | Concept Endosteal Fixation DeviceHWC · Traditional | 05/01/1992SE |
| K912957 | Concept MicromillHRX · Traditional | 10/04/1991SE |
| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Suture Cutter cleared by the FDA?
Suture Cutter (K770163) received a 510(k) decision of Substantially Equivalent on March 30, 1977, 64 days after the submission was received.
What is the product code of K770163?
The FDA product code is JOK – Scissors, Medical, Disposable, a Class I (low risk) device regulated under 21 CFR 880.6820.