FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
K Number: K090078
·
Decision May 8, 2009
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
9
Review Days
116
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
- K Number
- K090078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3130
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iop, Inc.
- Date Received
- January 12, 2009
- Decision Date
- May 8, 2009
- Product Code
- NXM
- 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 |
|---|---|---|---|
| NXM | Prosthesis, Eyelid Spacer/Graft, Biologic | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NXM), ordered by most recent decision date.
View allOther Clearances by Iop, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K890598 | MOLTENO IMPLANT | Feb 27, 1989 | Substantially Equivalent |