Davol Laparoscopic Insufflation Tubing Set
FDA 510(k) K935503 · Davol, Inc.
510(k) numberK935503
Submission
- Device name
- Davol Laparoscopic Insufflation Tubing Set
- Applicant
- Davol, Inc.
Cranston, RI, US - Received
- November 16, 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
- HIF – Insufflator, Laparoscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1730
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | Karl Storz SE & CO. KG | 08/19/2026SE |
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)HIF · Traditional | Weyo Surgical Technology , Ltd. | 06/25/2026SE |
| K252318 | Insufflator (OPTO-IFL1000)HIF · Traditional | Guangdong Optomedic Technologies, Inc. | 04/16/2026SE |
| K250388 | Endoflator +HIF · Traditional | Karl Storz SE & CO. KG | 09/22/2025SE |
| K242772 | AirSurgN Insufflator (10030/AirSurgN)HIF · Traditional | SmartsurgN, Inc. | 04/11/2025SE |
| K243527 | High Flow Insufflation Unit (UHI-4)HIF · Traditional | Olympus Medical Systems Corporation | 01/13/2025SE |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional | Tautona Group | 10/15/2024SE |
| K232902 | EVA15 insufflatorHIF · Traditional | Palliare , Ltd. | 05/02/2024SE |
| K232464 | VereSee Optical Veres Needle SystemHIF · Traditional | Freyja Healthcare, LLC | 05/02/2024SE |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional | Tautona Group Research & Development, Co., LLC | 01/12/2024SE |
More from Tautona Group Research & Development, Co., LLC
| 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 |
| K941334 | Davol Laparoscopic Suction Irrigation ProbeHET · Traditional | 06/14/1994SE |
| K921405 | Davol Suction/Irrigator W/ Interchangeable TipHFG · Traditional | 03/25/1994SE |
| K926479 | Bard Laparoscopic Irrigator Pump SystemGCJ · Traditional | 03/01/1994SE |
Questions and answers
When was Davol Laparoscopic Insufflation Tubing Set cleared by the FDA?
Davol Laparoscopic Insufflation Tubing Set (K935503) received a 510(k) decision of Substantially Equivalent on March 7, 1994, 111 days after the submission was received.
What is the product code of K935503?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.