Punch, Surgical
The Surgical Punch is a hand-held instrument used to create circular or defined tissue defects during surgery, such as in dermatology for biopsy or in ophthalmology and other specialties for tissue resection or perforation. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRY, regulated under 21 CFR 878.4800, within the General and Plastic Surgery medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- LRY
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933516 | ACU-E PUNCH | Mar 24, 1994 | Substantially Equivalent | ACUDERM, INC. |
| K904869 | ELLIPSE PUNCH | Mar 06, 1991 | Substantially Equivalent | KRAMER CONST |
| K902636 | LIPOGEN RHEUMELISA DSDNA ASSAY | Jun 28, 1990 | Substantially Equivalent | LIPOGEN, INC. |
| K896303 | BIOPSY PUNCH | Feb 13, 1990 | Substantially Equivalent | PREMIER MEDICAL |
| K874357 | TAPERED PUNCH | Nov 23, 1987 | Substantially Equivalent | MED-TOOL, INC. |
| K874356 | PIN PUNCH | Nov 23, 1987 | Substantially Equivalent | MED-TOOL, INC. |
| K872388 | NAIL SET | Jul 23, 1987 | Substantially Equivalent | MED-TOOL, INC. |
FEI Numbers
This FDA classification entry is associated with 249 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 249 registration numbers. Click on an entry to view related FDA registrations.