Grice Foot Pedal Control/Reddick Irri/Aspir Syst
FDA 510(k) K914913 · Ideal Medical, Inc.
510(k) numberK914913
Submission
- Device name
- Grice Foot Pedal Control/Reddick Irri/Aspir Syst
- Applicant
- Ideal Medical, Inc.
Clearwater, FL, US - Received
- November 1, 1991
- Decision date
- December 31, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDJ – Clamp, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| 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 |
| K912540 | Contour-PortLJT · Traditional | 08/23/1991SESK |
| K911601 | Reddick Trocar and CannulaFSM · Traditional | 05/21/1991SE |
Questions and answers
When was Grice Foot Pedal Control/Reddick Irri/Aspir Syst cleared by the FDA?
Grice Foot Pedal Control/Reddick Irri/Aspir Syst (K914913) received a 510(k) decision of Substantially Equivalent on December 31, 1991, 60 days after the submission was received.
What is the product code of K914913?
The FDA product code is GDJ – Clamp, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.