Insufflator (OPTO-IFL1000)
FDA 510(k) K252318 · Guangdong Optomedic Technologies, Inc.
510(k) numberK252318
Submission
- Device name
- Insufflator (OPTO-IFL1000)
- Applicant
- Guangdong Optomedic Technologies, Inc.
Foshan, CN - Received
- July 25, 2025
- Decision date
- April 16, 2026
- 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 |
| 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 |
| K232401 | Disposable Veress NeedlesHIF · Traditional | Hangzhou Kangji Medical Instrument Co., Ltd. | 12/14/2023SE |
More from Hangzhou Kangji Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252697 | 3D LaparoscopeGCJ · Traditional | 10/29/2025SE |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE…GCJ · Traditional | 10/23/2024SE |
| K241530 | Stellar Imaging SystemGCJ · Traditional | 08/07/2024SE |
| K231342 | Insufflator (OPTO-IFL1000)HIF · Traditional | 09/20/2023SE |
| K230407 | FloNavi Open Field Fluorescence Imaging SystemOWN · Traditional | 07/17/2023SE |
| K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)GCJ · Traditional | 07/06/2023SE |
| K221861 | FloNavi Endoscopic Fluorescence Imaging SystemGCJ · Traditional | 02/18/2023SE |
| K221781 | Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KHGCJ · Traditional | 02/02/2023SE |
Questions and answers
When was Insufflator (OPTO-IFL1000) cleared by the FDA?
Insufflator (OPTO-IFL1000) (K252318) received a 510(k) decision of Substantially Equivalent on April 16, 2026, 265 days after the submission was received.
What is the product code of K252318?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.