FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSMED TISSUE EXPANDER
K Number: K010852
·
Decision Aug 13, 2001
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
9
Review Days
145
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Basic Information
- Device Name
- OSMED TISSUE EXPANDER
- K Number
- K010852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Iop, Inc.
- Date Received
- March 21, 2001
- Decision Date
- August 13, 2001
- Product Code
- NFM
- 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 |
|---|---|---|---|
| NFM | Expander, Tissue, Orbital | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NFM), ordered by most recent decision date.
View allOther Clearances by Iop, Inc.
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| K062252 | MOLTENO3 | Sep 27, 2006 | Substantially Equivalent |
| K053622 | SURGISIS OCULAR GRAFT | Mar 15, 2006 | 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 |
| K890598 | MOLTENO IMPLANT | Feb 27, 1989 | Substantially Equivalent |