MTP Disposable Equipment Covers, Karl Storz 15 Touch Screen
FDA 510(k) K091178 · Mtp Medical Technical Promotion GmbH
510(k) numberK091178
Submission
- Device name
- MTP Disposable Equipment Covers, Karl Storz 15 Touch Screen
- Applicant
- Mtp Medical Technical Promotion GmbH
El Segundo, CA, US - Received
- April 22, 2009
- Decision date
- July 31, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MMP – Cover, Barrier, Protective
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code MMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043234 | Light DrapeMMP · Traditional | Wrapped IN Comfort | 05/25/2005SE |
| K041501 | Guangzhou Fortunique Drapes, Bags and CoversMMP · Traditional | Guangzhou Fortunique , Ltd. | 11/30/2004SE |
| K040794 | Incubator CapeMMP · Traditional | Wrapped IN Comfort | 06/10/2004SE |
| K032065 | Medline Band Bags and Equipment CoversMMP · Traditional | Medline Industries, Inc. | 09/22/2003SE |
| K023540 | Snap Kover, Model 01-2020; Snap Kaps, Model 03-KP09MMP · Traditional | Valumed | 02/04/2003SE |
| K014239 | Medsurg Equipment CoversMMP · Traditional | International Medsurg Connection | 02/19/2002SE |
| K970885 | Ultrasound Systems DrapeMMP · Traditional | Protek Medical Products, Inc. | 09/22/1997SE |
| K962288 | Cover-All, Drape-It-All, Chair Sleve, X-Ray Sleeve, Headrest CoverMMP · Traditional | Pinnacle Products, Inc. | 01/30/1997SE |
| K961699 | Equipment CoversMMP · Traditional | United States Surgical, A Division of Tyco Healthc | 08/23/1996SE |
| K952241 | Protouch OvergloveMMP · Traditional | Cottrell, Ltd. | 08/07/1995SE |
More from Cottrell, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 MTP Disposable Equipment Covers, Karl Storz 15 Touch Screen cleared by the FDA?
MTP Disposable Equipment Covers, Karl Storz 15 Touch Screen (K091178) received a 510(k) decision of Substantially Equivalent on July 31, 2009, 100 days after the submission was received.
What is the product code of K091178?
The FDA product code is MMP – Cover, Barrier, Protective, a Class II (moderate risk) device regulated under 21 CFR 878.4370.