Reddick Irrigation/Aspiration System
FDA 510(k) K910117 · Ideal Medical, Inc.
510(k) numberK910117
Submission
- Device name
- Reddick Irrigation/Aspiration System
- Applicant
- Ideal Medical, Inc.
Clearwater, FL, US - Received
- January 11, 1991
- Decision date
- March 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K944067 | Peanut Wand, ModificationGCS · Traditional | 12/08/1994SE |
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| K926335 | Ideas Peanut WandGCJ · Traditional | 06/24/1993SE |
| K922161 | Grice Soft Tissue Biopsy KitKNW · Traditional | 10/13/1992SE |
| K921922 | Grice Laparoscopic Suturing NeedleGCJ · Traditional | 07/08/1992SE |
| K915175 | Reddick RetractorGAD · Traditional | 04/29/1992SE |
| K914880 | Dual Balloon Embolectomy CatheterDXE · Traditional | 03/16/1992SE |
| K913602 | Ideas' PortFMF · Traditional | 01/02/1992SESK |
| K914913 | Grice Foot Pedal Control/Reddick Irri/Aspir SystGDJ · Traditional | 12/31/1991SE |
| K912540 | Contour-PortLJT · Traditional | 08/23/1991SESK |
Questions and answers
When was Reddick Irrigation/Aspiration System cleared by the FDA?
Reddick Irrigation/Aspiration System (K910117) received a 510(k) decision of Substantially Equivalent on March 19, 1991, 67 days after the submission was received.
What is the product code of K910117?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.