FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VOLUMATIC
K Number: K844169
·
Decision Nov 9, 1984
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
2
Applicant Total
4
Review Days
15
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Basic Information
- Device Name
- VOLUMATIC
- K Number
- K844169
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Glaxo, Inc.
- Date Received
- October 25, 1984
- Decision Date
- November 9, 1984
- Product Code
- KCD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KCD | Bougie, Esophageal, Ent | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KCD), ordered by most recent decision date.
ESOPHAGEAL BOUGIES
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Glaxo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954041 | G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES) | Oct 16, 1995 | Substantially Equivalent |
| K922187 | COMPACT SPACER | Nov 20, 1992 | Substantially Equivalent |
| K901803 | SYRINGE NEEDLE INTRODUCER | Nov 20, 1990 | Substantially Equivalent |