Insufflator, Laparoscopic
FDA 510(k) K920959 · Mectra Labs, Inc.
510(k) numberK920959
Submission
- Device name
- Insufflator, Laparoscopic
- Applicant
- Mectra Labs, Inc.
Bloomfield, IN, US - Received
- February 25, 1992
- Decision date
- July 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 |
|---|---|---|
| K113080 | TubalgatorHIN · Traditional | 06/29/2012SE |
| K033880 | Electro-LubeGEI · Traditional | 03/10/2004SE |
| K021247 | Pneumoperitoneum Insufflation NeedleHIF · Traditional | 11/08/2002SE |
| K993604 | Endoscopic Anti Fog DeviceOCT · Traditional | 03/03/2000SE |
| K955352 | Suction Cautery ProbeGEI · Traditional | 04/05/1996SE |
| K934547 | Mectra TrocarGCJ · Traditional | 02/18/1994SE |
| K935382 | GraspersGCJ · Traditional | 02/15/1994SE |
| K925691 | Insufflation TubingHIF · Traditional | 09/23/1993SE |
Questions and answers
When was Insufflator, Laparoscopic cleared by the FDA?
Insufflator, Laparoscopic (K920959) received a 510(k) decision of Substantially Equivalent on July 13, 1992, 139 days after the submission was received.
What is the product code of K920959?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.