Punch, Corneo-Scleral
A Corneo-Scleral Punch is a surgical instrument used in ophthalmic surgery to cut precise circular sections of corneal or scleral tissue, commonly employed during corneal transplantation to prepare the donor button or recipient bed. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification. It carries product code HNJ and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
Basic Information
- Product Code
- HNJ
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K871646 | TANNE CORNEAL CUTTING BLOCK | May 18, 1987 | Substantially Equivalent | OCULAR INSTRUMENTS, INC. |
| K830335 | DORC CORNEAL PUNCH BLOCK | Mar 09, 1983 | Substantially Equivalent | JEDMED INSTRUMENT CO. |
| K791988 | REPL. PISTON FOR TROUTMAN CORNEAL PUNCH | Oct 30, 1979 | Substantially Equivalent | EDWARD WECK, INC. |
FEI Numbers
This FDA classification entry is associated with 79 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 79 registration numbers. Click on an entry to view related FDA registrations.