Surgical Products, Skin Staple Remover
FDA 510(k) K822963 · Temp-Stik Corp.
510(k) numberK822963
Submission
- Device name
- Surgical Products, Skin Staple Remover
- Applicant
- Temp-Stik Corp.
Mchenry, IL, US - Received
- October 5, 1982
- Decision date
- November 8, 1982
- 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 |
| K830704 | One Time Disposable Skin StaplerFZQ · Traditional | Acme United Corp. | 04/12/1983SE |
| K822145 | CompleteFZQ · Traditional | Richard-Allan Medical Ind., Inc. | 10/22/1982SE |
More from Richard-Allan Medical Ind., Inc.
Questions and answers
When was Surgical Products, Skin Staple Remover cleared by the FDA?
Surgical Products, Skin Staple Remover (K822963) received a 510(k) decision of Substantially Equivalent on November 8, 1982, 34 days after the submission was received.
What is the product code of K822963?
The FDA product code is FZQ – Clip, Removable (Skin), a Class I (low risk) device regulated under 21 CFR 878.4320.