Iolab Power I.V. Pole
FDA 510(k) K921135 · Site Microsurgical Systems, Inc.
510(k) numberK921135
Submission
- Device name
- Iolab Power I.V. Pole
- Applicant
- Site Microsurgical Systems, Inc.
Horsham, PA, US - Received
- March 10, 1992
- Decision date
- June 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925828 | Modified Site TXR SystemsHQC · Traditional | 02/16/1994SE |
| K925921 | Modified Site Disposable Diaphragm CassetteKYG · Traditional | 12/06/1993SE |
| K931866 | Site's CD II Phacoemulsification HandpieceHQC · Traditional | 11/12/1993SE |
| K920582 | 180 Tip, 1/A Handpiece .3MM End Opening for Opht.HQE · Traditional | 05/08/1992SE |
| K912902 | Phacoemulsification System for Ophthalmic UseHQC · Traditional | 12/17/1991SE |
| K912739 | Site 90 Tip, I/A Handpiece .3MM Side Open/Opth UseHQC · Traditional | 08/28/1991SE |
| K910980 | Site 20 Gauge Reusable Fiber Optic CableHJO · Traditional | 05/22/1991SE |
| K905620 | Modified Site Peristaltic FootswitchEBW · Traditional | 02/27/1991SE |
| K904183 | Site Phacoemulsification HandpieceHQC · Traditional | 12/05/1990SE |
| K904151 | Site 19 Gauge Ultrasonic I/A Phaco NeedleHQC · Traditional | 12/05/1990SE |
Questions and answers
When was Iolab Power I.V. Pole cleared by the FDA?
Iolab Power I.V. Pole (K921135) received a 510(k) decision of Substantially Equivalent on June 3, 1992, 85 days after the submission was received.
What is the product code of K921135?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.