FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CYSTOTOMES/KNIFES
K Number: K880345
·
Decision May 3, 1988
Classifications
1
FEI Numbers
80
Registration Numbers
81
Same Product Code
19
Applicant Total
15
Review Days
98
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Basic Information
- Device Name
- CYSTOTOMES/KNIFES
- K Number
- K880345
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Myocure, Inc.
- Date Received
- January 26, 1988
- Decision Date
- May 3, 1988
- Product Code
- HNY
- 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 |
|---|---|---|---|
| HNY | Cystotome | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNY), ordered by most recent decision date.
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
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PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
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PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
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PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
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FDA Class 1
·Ophthalmic
PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
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 |
| 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 |
| K863663 | OPHTHALMIC SURGICAL OCULAR MARKERS | Oct 20, 1986 | Substantially Equivalent |
| K863662 | OPHTHALMIC SURGICAL DRAPE | Oct 20, 1986 | Substantially Equivalent |
| K863665 | THE ULTIMATE | Sep 25, 1986 | Substantially Equivalent |