Clip, Removable (Skin)
The Clip, Removable (Skin) (product code FZQ) is an external skin clip used to temporarily approximate wound edges during healing, designed for removal once the wound has closed sufficiently. It is classified as FDA Class 1, the lowest risk level, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4320 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- FZQ
- Device Class
- FDA class 1
- Regulation Number
- 878.4320
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K884783 | RANEY CLIP | Nov 30, 1988 | Substantially Equivalent | Alto Development Corp. |
| K873744 | LEUKOCLIP(R) | Sep 30, 1987 | Substantially Equivalent | Beiersdorf, Inc. |
| K830768 | DISPOSABLE SKIN STAPLER | Apr 12, 1983 | Substantially Equivalent | Surgeons Choice, Inc. |
| K830704 | ONE TIME DISPOSABLE SKIN STAPLER | Apr 12, 1983 | Substantially Equivalent | Acme United Corp. |
| K822963 | SURGICAL PRODUCTS, SKIN STAPLE REMOVER | Nov 08, 1982 | Substantially Equivalent | Temp-Stik Corp. |
| K822145 | COMPLETE | Oct 22, 1982 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
FEI Numbers
This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.