I/A/Kpe Tip
FDA 510(k) K864726 · Ipax, Inc.
510(k) numberK864726
Submission
- Device name
- I/A/Kpe Tip
- Applicant
- Ipax, Inc.
Englewood, CO, US - Received
- October 27, 1986
- Decision date
- January 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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| K915118 | Phaco Emulsification,Irrigation/Aspiration TubeHQC · Traditional | 12/27/1991SE |
| K914221 | Kpe 220 TS, NonsterileHQE · Traditional | 10/25/1991SE |
| K914172 | Kpe 230 AmHQC · Traditional | 10/25/1991SE |
| K884076 | Surebreath DomeGAD · Traditional | 10/07/1988SE |
| K873097 | Procedual Changes/Assembly Process for Plus PaksGBQ · Traditional | 09/04/1987SE |
| K870770 | Timleine(Tm) Venipuncture SystemKMK · Traditional | 04/23/1987SE |
Questions and answers
When was I/A/Kpe Tip cleared by the FDA?
I/A/Kpe Tip (K864726) received a 510(k) decision of Substantially Equivalent on January 20, 1987, 85 days after the submission was received.
What is the product code of K864726?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.