Davol Laparoscopic Suction Irrigation Probe
FDA 510(k) K941334 · Davol, Inc.
510(k) numberK941334
Submission
- Device name
- Davol Laparoscopic Suction Irrigation Probe
- Applicant
- Davol, Inc.
Cranston, RI, US - Received
- March 18, 1994
- Decision date
- June 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K200216 | 4K UHD Camera SystemHET · Traditional | Scivita Medical Technology Co., Ltd. | 08/21/2020SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251557 | Bard® Mesh; Bard® Mesh Pre-ShapedFTL · Special | 06/12/2025SE |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-ShapedFTL · Traditional | 04/09/2025SE |
| K031213 | Aquasens Fluid Monitoring SystemHIG · Traditional | 04/30/2003SE |
| K030307 | Davol Arthrovent Outflow TubingHRX · Traditional | 02/13/2003SE |
| K003323 | Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205FTL · Traditional | 01/22/2001SE |
| K003790 | Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002…GCJ · Traditional | 12/22/2000SE |
| K931899 | Davol AtsCAC · Traditional | 11/15/1994SE |
| K921405 | Davol Suction/Irrigator W/ Interchangeable TipHFG · Traditional | 03/25/1994SE |
| K935503 | Davol Laparoscopic Insufflation Tubing SetHIF · Traditional | 03/07/1994SE |
| K926479 | Bard Laparoscopic Irrigator Pump SystemGCJ · Traditional | 03/01/1994SE |
Questions and answers
When was Davol Laparoscopic Suction Irrigation Probe cleared by the FDA?
Davol Laparoscopic Suction Irrigation Probe (K941334) received a 510(k) decision of Substantially Equivalent on June 14, 1994, 88 days after the submission was received.
What is the product code of K941334?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.