The Karl Storz Mini 9000 Solid State CCD Video Cam
FDA 510(k) K881014 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK881014
Submission
- Device name
- The Karl Storz Mini 9000 Solid State CCD Video Cam
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- March 10, 1988
- Decision date
- April 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWF – Camera, Television, Endoscopic, Without Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FWF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053412 | Flexiscope, Models 50MH and 50 MHCFWF · Traditional | Schoelly Imaging, Inc. | 02/23/2006SE |
| K990154 | Karl Storz Direct Coupled Interface (Dci 5) Camera SystemFWF · Traditional | Karl Storz Imaging, Inc. | 06/01/1999SE |
| K982754 | EC-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (NTSC)FWF · Traditional | A.Stein - Regulatory Affairs Consulting | 01/08/1999SE |
| K982965 | Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesFWF · Traditional | Richard Wolf Medical Instruments Corp. | 11/23/1998SE |
| K982397 | Ves 3001-M Complete Video Endoscopic SystemFWF · Traditional | Angiolaz, Inc. | 09/10/1998SE |
| K982409 | Ves 1501-MFWF · Traditional | Angiolaz, Inc. | 08/21/1998SE |
| K981819 | Angiolaz VES-1CAMFWF · Traditional | Angiolaz, Inc. | 08/04/1998SE |
| K944707 | Isolated Camera HeadFWF · Traditional | Envision Medical Corp. | 10/07/1994SE |
| K930297 | Fujinon Video Laparoscope, ModifiedFWF · Traditional | Fujinon, Inc. | 03/29/1994SE |
| K934682 | Surgical Video Camera and AccessoriesFWF · Traditional | Medical Dynamics, Inc. | 02/15/1994SE |
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| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
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Questions and answers
When was The Karl Storz Mini 9000 Solid State CCD Video Cam cleared by the FDA?
The Karl Storz Mini 9000 Solid State CCD Video Cam (K881014) received a 510(k) decision of Substantially Equivalent on April 14, 1988, 35 days after the submission was received.
What is the product code of K881014?
The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.