Peanut Wand, Modification
FDA 510(k) K944067 · Ideal Medical, Inc.
510(k) numberK944067
Submission
- Device name
- Peanut Wand, Modification
- Applicant
- Ideal Medical, Inc.
Clearwater, FL, US - Received
- July 26, 1994
- Decision date
- December 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCS – Endoscope, Battery-Powered And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944062 | Laprascopic GrasperGCS · Traditional | Instrument Makar, Inc. | 02/23/1995SE |
| K933201 | Aesculap Trocar Instrument SetGCS · Traditional | Aesculap, Inc. | 09/13/1993SE |
| K932762 | 10.0MM Suction/Irrigation Probe & Tubing KitGCS · Traditional | Inman Medical Corp. | 08/31/1993SE |
| K933371 | Imc Endoscopic Instrument HolderGCS · Traditional | Inman Medical Corp. | 08/06/1993SE |
| K924134 | Leisegang Laparoscopic Irrigation System/AccessGCS · Traditional | Leisegang Medical, Inc. | 07/02/1993SE |
| K931340 | Grasp Forceps/Scissors/Needle Holder/DissectorGCS · Traditional | Baxter Healthcare Corp | 07/01/1993SE |
| K925276 | M.I.S. Trocar-CannulaGCS · Traditional | M.I.S. Technology, Inc. | 05/24/1993SE |
| K921006 | Laparoscopic Retractor SystemGCS · Traditional | Laparomed Corp. | 07/28/1992SE |
More from Laparomed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K931115 | Hatcher Stone-Embolis ExtractorLQR · Traditional | 08/20/1993SE |
| 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 |
| K911601 | Reddick Trocar and CannulaFSM · Traditional | 05/21/1991SE |
Questions and answers
When was Peanut Wand, Modification cleared by the FDA?
Peanut Wand, Modification (K944067) received a 510(k) decision of Substantially Equivalent on December 8, 1994, 135 days after the submission was received.
What is the product code of K944067?
The FDA product code is GCS – Endoscope, Battery-Powered And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.