Connecting Tubes
FDA 510(k) K831007 · Medovations, Inc.
510(k) numberK831007
Submission
- Device name
- Connecting Tubes
- Applicant
- Medovations, Inc.
Mchenry, IL, US - Received
- March 30, 1983
- Decision date
- May 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
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| K905478 | Yankauer Suction DeviceMDM · Traditional | 12/19/1990SE |
| K874309 | Urethal CatheterKNX · Traditional | 12/07/1987SE |
| K864963 | Stomach Evaculator - Ewald StyleKOA · Traditional | 10/14/1987SE |
| K864962 | Oberto Mouth PropJXL · Traditional | 02/19/1987SE |
| K864964 | 5 - in - 1 ConnectorGAZ · Traditional | 01/20/1987SE |
Questions and answers
When was Connecting Tubes cleared by the FDA?
Connecting Tubes (K831007) received a 510(k) decision of Substantially Equivalent on May 18, 1983, 49 days after the submission was received.
What is the product code of K831007?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.