Circon Acmi Cat.# Lap 9900; High Flow Insufflator
FDA 510(k) K914101 · Circon Video
510(k) numberK914101
Submission
- Device name
- Circon Acmi Cat.# Lap 9900; High Flow Insufflator
- Applicant
- Circon Video
Stanford, CT, US - Received
- September 12, 1991
- Decision date
- November 22, 1991
- 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 |
|---|---|---|
| K012758 | Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models…FGB · Traditional | 04/09/2002SE |
| K011876 | Dolphin II Fluid Management System, Model DOL-2HIG · Traditional | 01/08/2002SE |
| K011849 | MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes…FGB · Traditional | 12/10/2001SE |
| K012929 | Flexible Pediatric Cystoureteroscope, Model Aur- 735FAJ · Traditional | 11/19/2001SE |
| K012951 | APN-2 USA Series Flexible CholedochoscopeFGB · Traditional | 11/09/2001SE |
| K012925 | DUR-8, Models DUR-8FGB · Traditional | 11/07/2001SE |
| K012265 | Metal Halide Light Source, Models MV-9088-T, MV-9088FCW · Traditional | 10/17/2001SE |
| K012153 | Lowsley Suprapubic TractorKOB · Traditional | 09/19/2001SE |
| K011848 | Circon AEH-4 Electrohydraulic Lithotripsy ProbeFFK · Traditional | 09/11/2001SE |
| K970595 | Circon Endotek OM-4 H2O Cystometry PumpFEN · Traditional | 10/24/1997SE |
Questions and answers
When was Circon Acmi Cat.# Lap 9900; High Flow Insufflator cleared by the FDA?
Circon Acmi Cat.# Lap 9900; High Flow Insufflator (K914101) received a 510(k) decision of Substantially Equivalent on November 22, 1991, 71 days after the submission was received.
What is the product code of K914101?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.