Gas Insufflator
FDA 510(k) K221995 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
510(k) numberK221995
Submission
- Device name
- Gas Insufflator
- Applicant
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Cixi, CN - Received
- July 6, 2022
- Decision date
- March 28, 2023
- 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 |
|---|---|---|
| K240376 | Electroporation System (N3000)OAB · Traditional | 10/04/2024SE |
| K212614 | Ultrasonic Scalpel SystemLFL · Traditional | 07/18/2022SE |
| K210488 | Ultrasonic Surgical & Electrosurgical GeneratorGEI · Traditional | 10/25/2021SE |
| K210116 | Video Endoscopy System, 3D Video Endoscopy SystemHET · Traditional | 10/13/2021SE |
| K183153 | Microwave Ablation SystemNEY · Traditional | 07/08/2019SE |
| K190052 | Radio Frequency Ablation SystemGEI · Traditional | 06/25/2019SE |
Questions and answers
When was Gas Insufflator cleared by the FDA?
Gas Insufflator (K221995) received a 510(k) decision of Substantially Equivalent on March 28, 2023, 265 days after the submission was received.
What is the product code of K221995?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.