Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)
FDA 510(k) K973558 · Ultracell Medical Technologies, Inc.
510(k) numberK973558
Submission
- Device name
- Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)
- Applicant
- Ultracell Medical Technologies, Inc.
North Stonington, CT, US - Received
- September 19, 1997
- Decision date
- November 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEB – Accessories, Cleaning, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB · Special | STERIS Corporation | 12/02/2024SE |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB · Traditional | STERIS Corporation | 06/30/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | Medivators, Inc. | 01/14/2022SE |
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| K173590 | System 83 Plus Washer/DisinfectorFEB · Traditional | Custom Ultrasonics, Inc. | 03/30/2020SE |
| K190969 | ENDOSCOPE REPROCESSOR OER-EliteFEB · Traditional | Olympus Medical Systems Corp. | 07/09/2019SE |
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| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid SystemFEB · Traditional | STERIS Corporation | 12/14/2018SE |
| K172677 | Advantage Plus Pass-ThruFEB · Traditional | Medivators, Inc. | 12/19/2017SE |
More from Medivators, Inc.
| 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 |
| 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 |
| K950372 | Ultracell Orthopedic SpongesGDY · Traditional | 04/17/1995SE |
Questions and answers
When was Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus) cleared by the FDA?
Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus) (K973558) received a 510(k) decision of Substantially Equivalent on November 24, 1997, 66 days after the submission was received.
What is the product code of K973558?
The FDA product code is FEB – Accessories, Cleaning, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.