FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPHTHALMIC SURGICAL OCULAR MARKERS
K Number: K863663
·
Decision Oct 20, 1986
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
4
Applicant Total
15
Review Days
32
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Basic Information
- Device Name
- OPHTHALMIC SURGICAL OCULAR MARKERS
- K Number
- K863663
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Myocure, Inc.
- Date Received
- September 18, 1986
- Decision Date
- October 20, 1986
- Product Code
- HMR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HMR | Marker, Ocular | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HMR), ordered by most recent decision date.
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
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LASER CENTERING DEVICE
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OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
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Other Clearances by Myocure, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880347 | ANESTHESIA/RETROBULBAR NEEDLES | May 3, 1988 | Substantially Equivalent |
| K880346 | CANNULAS | May 3, 1988 | Substantially Equivalent |
| K880345 | CYSTOTOMES/KNIFES | May 3, 1988 | Substantially Equivalent |
| K874057 | OPHTHALMIC TIP & BLADE SCALPELS | Dec 23, 1987 | Substantially Equivalent |
| K874056 | OPHTHALMIC DISPOSABLE BLADES | Dec 22, 1987 | Substantially Equivalent |
| K873385 | OPHTHALMIC PHACO-BLADE | Sep 21, 1987 | Substantially Equivalent |
| K864371 | SURGICAL SKIN MARKER | Nov 17, 1986 | Substantially Equivalent |
| K863666 | THE SAVER KIT | Oct 20, 1986 | Substantially Equivalent |
| K863662 | OPHTHALMIC SURGICAL DRAPE | Oct 20, 1986 | Substantially Equivalent |
| K863665 | THE ULTIMATE | Sep 25, 1986 | Substantially Equivalent |