Unidrive II Plus Disposable Tubing Set
FDA 510(k) K021811 · Mtp Medical Technical Promotion GmbH
510(k) numberK021811
Submission
- Device name
- Unidrive II Plus Disposable Tubing Set
- Applicant
- Mtp Medical Technical Promotion GmbH
Culver City, CA, US - Received
- June 3, 2002
- Decision date
- June 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
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| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL · Traditional | Stryker Corporation | 09/15/2017SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K091178 | MTP Disposable Equipment Covers, Karl Storz 15 Touch ScreenMMP · Traditional | 07/31/2009SE |
| K020599 | MTP Clearvision Disposable Tubing SetEOB · Traditional | 03/13/2002SE |
| K011360 | MTP Laparomat Disposable Tubing SetGCJ · Traditional | 07/19/2001SE |
| K000337 | MTP Disposable Trocar ValvesGCJ · Traditional | 04/12/2000SE |
| K994066 | MTP Disposable TrocarsGCJ · Traditional | 01/20/2000SE |
| K990912 | MTP Extraction BagGCJ · Traditional | 06/09/1999SE |
| K990909 | MTP Uropump Disposable Tubing SetLJH · Traditional | 06/09/1999SE |
| K990911 | MTP Arthropump Disposable Tubing SetHRX · Traditional | 06/03/1999SE |
| K990910 | MTP Hamou Endomat Disposable Tubing SetsHIH · Traditional | 06/03/1999SE |
Questions and answers
When was Unidrive II Plus Disposable Tubing Set cleared by the FDA?
Unidrive II Plus Disposable Tubing Set (K021811) received a 510(k) decision of Substantially Equivalent on June 19, 2002, 16 days after the submission was received.
What is the product code of K021811?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.