Flowgun Reusable Irrigation Probes
FDA 510(k) K935645 · O.R. Concepts, Inc.
510(k) numberK935645
Submission
- Device name
- Flowgun Reusable Irrigation Probes
- Applicant
- O.R. Concepts, Inc.
Burnsville, MN, US - Received
- November 23, 1993
- Decision date
- March 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K941337 | Flowgun Electrocautery ProbesGEI · Traditional | 08/17/1994SE |
| K935971 | Flowgun Electrocautery ProbesGEI · Traditional | 05/16/1994SE |
| K935970 | Flowgun Electrocautery Probe HandleGEI · Traditional | 05/16/1994SE |
| K926242 | Orc Endoscopic Monopolar Electrosurgical ProbeGEI · Traditional | 10/15/1993SE |
| K922244 | Insufflator Tubing/Filter KitHIF · Traditional | 09/24/1993SE |
| K922197 | Insufflator Tubing KitHIG · Traditional | 09/24/1993SE |
| K932449 | Dr. FogOCT · Traditional | 08/11/1993SE |
| K925147 | Orc 10.0MM Suction ProbeGCJ · Traditional | 06/25/1993SE |
| K925024 | Orc Tappered Irrigating ProbeGCY · Traditional | 05/21/1993SE |
| K923908 | # 9455 and #9457 Poole Tip Suction ProbeGCY · Traditional | 05/17/1993SE |
Questions and answers
When was Flowgun Reusable Irrigation Probes cleared by the FDA?
Flowgun Reusable Irrigation Probes (K935645) received a 510(k) decision of Substantially Equivalent on March 7, 1994, 104 days after the submission was received.
What is the product code of K935645?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.