FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
K Number: K971832
·
Decision Jul 31, 1997
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
3
Review Days
73
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
- IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
- K Number
- K971832
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- M-Pact Worldwide Management Corp.
- Date Received
- May 19, 1997
- Decision Date
- July 31, 1997
- 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
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
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