Scb/Steris Or-Light Interface Box
FDA 510(k) K051505 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK051505
Submission
- Device name
- Scb/Steris Or-Light Interface Box
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- June 7, 2005
- Decision date
- August 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTA – Light, Surgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
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Questions and answers
When was Scb/Steris Or-Light Interface Box cleared by the FDA?
Scb/Steris Or-Light Interface Box (K051505) received a 510(k) decision of Substantially Equivalent on August 11, 2005, 65 days after the submission was received.
What is the product code of K051505?
The FDA product code is FTA – Light, Surgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4580.