FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
K Number: K091240
·
Decision Oct 23, 2009
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
4
Review Days
179
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
- ALPHAMED SURGICAL SPEAR, MODEL 70-5000
- K Number
- K091240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alphamed, Inc.
- Date Received
- April 27, 2009
- Decision Date
- October 23, 2009
- Product Code
- HOZ
- 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 |
|---|---|---|---|
| HOZ | Sponge, Ophthalmic | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOZ), ordered by most recent decision date.
SUNTOUCH EYE SPEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
FDA 510(k)
FDA Class 2
·Ophthalmic
CENEFOM PVA SURGICAL SPEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
ULTRACELL ABSORBENT STICK
FDA 510(k)
FDA Class 2
·Ophthalmic
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
FDA 510(k)
FDA Class 2
·Ophthalmic
PRESCOTT'S SURGICAL SPEAR
FDA 510(k)
FDA Class 2
·Ophthalmic