Arthroscope
FDA 510(k) K931792 · Intramed Laboratories, Inc.
510(k) numberK931792
Submission
- Device name
- Arthroscope
- Applicant
- Intramed Laboratories, Inc.
San Diego, CA, US - Received
- April 12, 1993
- Decision date
- June 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRH – Trephine, Manual, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
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| K904465 | Flexible ArthroscopeHRX · Traditional | 12/20/1990SE |
| K903528 | LaparoscopeHET · Traditional | 09/04/1990SE |
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Questions and answers
When was Arthroscope cleared by the FDA?
Arthroscope (K931792) received a 510(k) decision of Substantially Equivalent on June 13, 1994, 427 days after the submission was received.
What is the product code of K931792?
The FDA product code is HRH – Trephine, Manual, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.