CO2 Insufflation Tubing
FDA 510(k) K922038 · Surgeon Surgical Instrumentation, Inc.
510(k) numberK922038
Submission
- Device name
- CO2 Insufflation Tubing
- Applicant
- Surgeon Surgical Instrumentation, Inc.
Placentia, CA, US - Received
- May 1, 1992
- Decision date
- October 13, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K954241 | Surgin Genisis PhacoemulsifierHQC · Traditional | 12/01/1995SE |
| K932281 | Verres NeedleGCT · Traditional | 08/06/1993SE |
| K904010 | Surgical Aspirator KitLFL · Traditional | 11/21/1990SE |
| K890447 | Hemorrhage OccludorGDW · Traditional | 02/23/1989SE |
| K880543 | Uni-PortKYG · Traditional | 07/01/1988SE |
| K881232 | Surgin Eye ShieldHOY · Traditional | 04/13/1988SE |
| K861203 | Multi-SpikeKYG · Traditional | 04/28/1986SE |
| K852229 | Sterile Eye Packs or Trays · Traditional | 06/07/1985SE |
| K830859 | I/A KitGBX · Traditional | 05/02/1983SE |
Questions and answers
When was CO2 Insufflation Tubing cleared by the FDA?
CO2 Insufflation Tubing (K922038) received a 510(k) decision of Substantially Equivalent on October 13, 1992, 165 days after the submission was received.
What is the product code of K922038?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.