MTP Disposable Trocars
FDA 510(k) K994066 · Mtp Medical Technical Promotion GmbH
510(k) numberK994066
Submission
- Device name
- MTP Disposable Trocars
- Applicant
- Mtp Medical Technical Promotion GmbH
Culver City, CA, US - Received
- December 1, 1999
- Decision date
- January 20, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
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| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
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| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
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| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K091178 | MTP Disposable Equipment Covers, Karl Storz 15 Touch ScreenMMP · Traditional | 07/31/2009SE |
| K021811 | Unidrive II Plus Disposable Tubing SetERL · Traditional | 06/19/2002SE |
| 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 |
| 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 MTP Disposable Trocars cleared by the FDA?
MTP Disposable Trocars (K994066) received a 510(k) decision of Substantially Equivalent on January 20, 2000, 50 days after the submission was received.
What is the product code of K994066?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.