Irrigation, Aspiration Tubing Sets
FDA 510(k) K841072 · Innovative Surgical Products, Inc.
510(k) numberK841072
Submission
- Device name
- Irrigation, Aspiration Tubing Sets
- Applicant
- Innovative Surgical Products, Inc.
Santa Ana, CA, US - Received
- March 12, 1984
- Decision date
- March 29, 1984
- 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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More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843041 | Heslin Dispos. Tubing SetHQE · Traditional | 11/21/1984SE |
| K840695 | Phacoemulsification KitsHQC · Traditional | 05/22/1984SE |
| K840693 | Disposable Scleral Globe PlugLXP · Traditional | 05/22/1984SE |
| K840694 | Lens Insertion GlideKYB · Traditional | 05/09/1984SE |
| K832235 | Disposable Vitrectomy HandpieceHQE · Traditional | 09/29/1983SE |
| K821496 | Disposable Irriga/Aspir. SystemKDH · Traditional | 06/22/1982SE |
| K820765 | Pleural Drainage ReservoirGCX · Traditional | 04/15/1982SE |
| K820680 | Disposable Tubing SetsKYG · Traditional | 04/09/1982SE |
| K802973 | Ispvac TMGCY · Traditional | 12/19/1980SE |
| K801350 | Acuvac(Tm) Suction Reservoir 400CC andGCY · Traditional | 07/14/1980SE |
Questions and answers
When was Irrigation, Aspiration Tubing Sets cleared by the FDA?
Irrigation, Aspiration Tubing Sets (K841072) received a 510(k) decision of Substantially Equivalent on March 29, 1984, 17 days after the submission was received.
What is the product code of K841072?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.