Ultracell Instrument Wipe
FDA 510(k) K920353 · Ultracell Medical Technologies, Inc.
510(k) numberK920353
Submission
- Device name
- Ultracell Instrument Wipe
- Applicant
- Ultracell Medical Technologies, Inc.
North Stonington, CT, US - Received
- January 27, 1992
- Decision date
- September 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HEP – Monitor, Blood-Flow, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HEP
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| 510(k) | Device | Decision |
|---|---|---|
| K012196 | Ultracell Absorbent StickHOZ · Traditional | 08/24/2001SE |
| K972634 | Ultracell Suction SpongeGDY · Traditional | 12/17/1997SE |
| K972633 | Ultracell Suction SpongeHOZ · Traditional | 12/17/1997SE |
| K973083 | Ultracell Neuro SpongesHBA · Traditional | 12/09/1997SE |
| K973558 | Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)FEB · Traditional | 11/24/1997SE |
| K973085 | Ultracell Packing with SleeveEMX · Traditional | 11/18/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | 10/01/1997SE |
| K970328 | Ultracell Neuro SpongesHBA · Traditional | 04/21/1997SE |
| K950647 | Ultracell Neuro SpongesHBA · Traditional | 08/15/1995SE |
| K950373 | Ultracell Orthopedic SpongesGDY · Traditional | 04/17/1995SE |
Questions and answers
When was Ultracell Instrument Wipe cleared by the FDA?
Ultracell Instrument Wipe (K920353) received a 510(k) decision of Substantially Equivalent on September 15, 1992, 232 days after the submission was received.
What is the product code of K920353?
The FDA product code is HEP – Monitor, Blood-Flow, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 884.2660.