One Time Disposable Skin Stapler
FDA 510(k) K830704 · Acme United Corp.
510(k) numberK830704
Submission
- Device name
- One Time Disposable Skin Stapler
- Applicant
- Acme United Corp.
Mchenry, IL, US - Received
- March 7, 1983
- Decision date
- April 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZQ – Clip, Removable (Skin)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4320
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884783 | Raney ClipFZQ · Traditional | Alto Development Corp. | 11/30/1988SE |
| K873744 | Leukoclip(R)FZQ · Traditional | Beiersdorf, Inc. | 09/30/1987SE |
| K830768 | Disposable Skin StaplerFZQ · Traditional | Surgeons Choice, Inc. | 04/12/1983SE |
| K822963 | Surgical Products, Skin Staple RemoverFZQ · Traditional | Temp-Stik Corp. | 11/08/1982SE |
| K822145 | CompleteFZQ · Traditional | Richard-Allan Medical Ind., Inc. | 10/22/1982SE |
More from Richard-Allan Medical Ind., Inc.
| 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 One Time Disposable Skin Stapler cleared by the FDA?
One Time Disposable Skin Stapler (K830704) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 36 days after the submission was received.
What is the product code of K830704?
The FDA product code is FZQ – Clip, Removable (Skin), a Class I (low risk) device regulated under 21 CFR 878.4320.