FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRRIVAGE
K Number: K922785
·
Decision Oct 16, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
7
Review Days
129
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Basic Information
- Device Name
- IRRIVAGE
- K Number
- K922785
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Autovage
- Date Received
- June 9, 1992
- Decision Date
- October 16, 1992
- Product Code
- EYF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| EYF | Protector, Wound, Plastic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EYF), ordered by most recent decision date.
HARDING STERNAL SHIELD
FDA 510(k)
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·General, Plastic Surgery
ANTI-FOG DISPOSABLE IV INDUCTION COVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SI-PRO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
COMFEEL PROTECTIVE RINGS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Autovage
| K Number | Device Name | ||
|---|---|---|---|
| K914908 | QUICVAGE PLUS | Apr 13, 1992 | Unknown |
| K914907 | QUICVAGE | Jan 24, 1992 | Substantially Equivalent |
| K911788 | ECONOVAGE R | Jul 26, 1991 | Substantially Equivalent |
| K911919 | MINIVAGE(R) | Jul 26, 1991 | Substantially Equivalent |
| K840943 | ENDO-JECT | May 25, 1984 | Substantially Equivalent |
| K823195 | GASTRIC LAVAGE KIT | Dec 3, 1982 | Substantially Equivalent |