Lap 3501 High Flow Insufflator
FDA 510(k) K905705 · Circon Acmi
510(k) numberK905705
Submission
- Device name
- Lap 3501 High Flow Insufflator
- Applicant
- Circon Acmi
Stamford, CT, US - Received
- December 24, 1990
- Decision date
- February 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K013165 | USA Series LaparoscopesGCJ · Traditional | 01/18/2002SE |
| K980492 | AEH-3 Electrohydraulic Lithotripter and Probes (E-1F, E-3F, E-5F, and E-9F)FFK · Traditional | 11/17/1998SE |
| K905706 | GYN-1500 Hysteroscopic InufflatorHIG · Traditional | 02/28/1991SE |
| K884097 | Morris Anti-Splatter Device for EndoscopesODC · Traditional | 04/17/1989SE |
| K884025 | Circon Acmi Bicap II Therapeutic System BC-200KNS · Traditional | 03/03/1989SE |
| K884254 | Circon Acmi Bicap III Therapeutic SystemKNS · Traditional | 01/11/1989SE |
| K884252 | Circon Acmi Bicap Hemorrhoid System BH-10 & BHP-20KNS · Traditional | 01/10/1989SE |
| K884306 | Bicap Ablating Forceps BAF-7KNS · Traditional | 01/05/1989SE |
| K883819 | Bullard Intubating Laryngoscope Lar-A & Lar-PCCW · Traditional | 10/17/1988SE |
Questions and answers
When was Lap 3501 High Flow Insufflator cleared by the FDA?
Lap 3501 High Flow Insufflator (K905705) received a 510(k) decision of Substantially Equivalent on February 28, 1991, 66 days after the submission was received.
What is the product code of K905705?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.