3000 Electronic Insufflator Modification
FDA 510(k) K934115 · Cabot Medical Corp.
510(k) numberK934115
Submission
- Device name
- 3000 Electronic Insufflator Modification
- Applicant
- Cabot Medical Corp.
Langhorne, PA, US - Received
- August 24, 1993
- Decision date
- March 15, 1995
- 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 |
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| K946109 | Cabot Medical Reusable Bipolar Cutting ForcepsKNS · Traditional | 11/21/1995SE |
| K951972 | Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic SheathsFBO · Traditional | 07/21/1995SE |
| K951714 | Cabot Medical-Surgitek Ultragold Plus Side-Firing Urologic Laser FiberGEX · Traditional | 07/11/1995SE |
| K941743 | Cabot Medical Niagara Fluid Management PumpHIG · Traditional | 04/19/1995SE |
| K932293 | Cabot Medical Bipolar Cutting ForcepsKNS · Traditional | 07/27/1994SE |
| K930954 | The Cabot Medical Insul-Sheth Vaginal Speculum CovHIB · Traditional | 06/30/1994SE |
| K932626 | Cabot Medical Surgiflex(R) Suction-Irrigation ProbGCJ · Traditional | 06/08/1994SE |
| K935786 | Corson and Nezhat Suction/Irrigation ProbesGCJ · Traditional | 05/19/1994SE |
| K924631 | Cabot Medical Uterine ResectoscopeHIH · Traditional | 05/16/1994SE |
Questions and answers
When was 3000 Electronic Insufflator Modification cleared by the FDA?
3000 Electronic Insufflator Modification (K934115) received a 510(k) decision of Substantially Equivalent on March 15, 1995, 568 days after the submission was received.
What is the product code of K934115?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.