Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories
FDA 510(k) K982965 · Richard Wolf Medical Instruments Corp.
510(k) numberK982965
Submission
- Device name
- Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- August 25, 1998
- Decision date
- November 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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| K982409 | Ves 1501-MFWF · Traditional | Angiolaz, Inc. | 08/21/1998SE |
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| 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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Questions and answers
When was Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories cleared by the FDA?
Endocam Camera Systems 5502/5507 with CR Camera Heads and Accessories (K982965) received a 510(k) decision of Substantially Equivalent on November 23, 1998, 90 days after the submission was received.
What is the product code of K982965?
The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.