FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOLTENO IMPLANT
K Number: K890598
·
Decision Feb 27, 1989
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
24
Applicant Total
9
Review Days
21
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Basic Information
- Device Name
- MOLTENO IMPLANT
- K Number
- K890598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3920
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Iop, Inc.
- Date Received
- February 6, 1989
- Decision Date
- February 27, 1989
- Product Code
- KYF
- 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 |
|---|---|---|---|
| KYF | Implant, Eye Valve | FDA class 2 | Ophthalmic |
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Other Clearances by Iop, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090078 | KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT | May 8, 2009 | Substantially Equivalent |
| K062252 | MOLTENO3 | Sep 27, 2006 | Substantially Equivalent |
| K053622 | SURGISIS OCULAR GRAFT | Mar 15, 2006 | Substantially Equivalent |
| K010852 | OSMED TISSUE EXPANDER | Aug 13, 2001 | Substantially Equivalent |
| K003646 | SUTUREGROOVE WEIGHT SIZING SET | Feb 22, 2001 | Unknown |
| K994289 | SUTUREGROOVE | Apr 17, 2000 | Substantially Equivalent |
| K972143 | MOA BONE / M-SPHERE | Oct 16, 1997 | Substantially Equivalent |
| K902489 | MODIFIED MOLTENO(TM) IMPLANTS | Aug 14, 1990 | Substantially Equivalent |