Si Controller Model Si 500
FDA 510(k) K960492 · I.C Medical, Inc.
510(k) numberK960492
Submission
- Device name
- Si Controller Model Si 500
- Applicant
- I.C Medical, Inc.
Glendale, AZ, US - Received
- February 2, 1996
- Decision date
- December 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| K953418 | Electrocautery ShroudGCJ · Traditional | 10/07/1995SE |
| K954088 | Telescoping PenevacGEI · Traditional | 09/22/1995SE |
| K932230 | Crystal Vision and AccessoriesFYD · Traditional | 02/18/1994SE |
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Questions and answers
When was Si Controller Model Si 500 cleared by the FDA?
Si Controller Model Si 500 (K960492) received a 510(k) decision of Substantially Equivalent on December 23, 1996, 325 days after the submission was received.
What is the product code of K960492?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.