FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRACELL INSTRUMENT WIPE
K Number: K920353
·
Decision Sep 15, 1992
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
3
Applicant Total
24
Review Days
232
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Basic Information
- Device Name
- ULTRACELL INSTRUMENT WIPE
- K Number
- K920353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ultracell Medical Technologies, Inc.
- Date Received
- January 27, 1992
- Decision Date
- September 15, 1992
- Product Code
- HEP
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HEP | Monitor, Blood-Flow, Ultrasonic | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HEP), ordered by most recent decision date.
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BABYCARE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POCKET DOP 3
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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 |
| K973085 | ULTRACELL PACKING WITH SLEEVE | Nov 18, 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 |