FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRACELL PACKING WITH SLEEVE
K Number: K973085
·
Decision Nov 18, 1997
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
24
Review Days
92
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
- ULTRACELL PACKING WITH SLEEVE
- K Number
- K973085
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ultracell Medical Technologies, Inc.
- Date Received
- August 18, 1997
- Decision Date
- November 18, 1997
- Product Code
- EMX
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMX), ordered by most recent decision date.
PosiSep X BAM Hemostat Dressing/Intranasal Splint
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NASALCEASE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HYLASINE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HYDROFERA BACTERISTATIC NASAL DRESSING
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MEROGEL NASAL DRESSING AND SINUS STENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Ultracell Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012196 | ULTRACELL ABSORBENT STICK | Aug 24, 2001 | Substantially Equivalent |
| K972633 | ULTRACELL SUCTION SPONGE | Dec 17, 1997 | Substantially Equivalent |
| K972634 | ULTRACELL SUCTION SPONGE | Dec 17, 1997 | Substantially Equivalent |
| K973083 | ULTRACELL NEURO SPONGES | Dec 9, 1997 | Substantially Equivalent |
| K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) | Nov 24, 1997 | Substantially Equivalent |
| K972635 | ULTRACELL SUCTION SPONGE | Oct 1, 1997 | Substantially Equivalent |
| K970328 | ULTRACELL NEURO SPONGES | Apr 21, 1997 | Substantially Equivalent |
| K950647 | ULTRACELL NEURO SPONGES | Aug 15, 1995 | Substantially Equivalent |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | Apr 17, 1995 | Substantially Equivalent |
| K950373 | ULTRACELL ORTHOPEDIC SPONGES | Apr 17, 1995 | Substantially Equivalent |