Humi-Flow, Model 6-850-00/ 01/02
FDA 510(k) K010053 · Northgate Technologies, Inc.
510(k) numberK010053
Submission
- Device name
- Humi-Flow, Model 6-850-00/ 01/02
- Applicant
- Northgate Technologies, Inc.
Elgin, IL, US - Received
- January 8, 2001
- Decision date
- October 23, 2001
- 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 |
| 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 |
|---|---|---|
| K202813 | URO-TOUCH 9 French ProbeFFK · Traditional | 06/14/2021SE |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemFYD · Traditional | 03/25/2021SE |
| K130368 | Autolith Touch; Uro TouchFFK · Traditional | 11/15/2013SE |
| K120151 | Nebulae IHIF · Traditional | 08/17/2012SE |
| K041560 | Flo-AssistantHIF · Traditional | 09/28/2004SE |
| K033614 | Mistic Humidification System 850-00/01/02, 2215HIF · Traditional | 07/29/2004SE |
| K022052 | 40LPM Abdominal Insufflator, Catalog # 72-00203-0HIF · Traditional | 01/24/2003SE |
| K011928 | Hydrotower Arthroscopic Administration Tubing Set, Model 7-460-05FPA · Traditional | 08/10/2001SE |
| K001325 | Flo Assistant, Model 4-250-00LJH · Traditional | 08/18/2000SE |
| K993778 | Hydrotower Management System, Model 4-750-00OCX · Special | 01/06/2000SE |
Questions and answers
When was Humi-Flow, Model 6-850-00/ 01/02 cleared by the FDA?
Humi-Flow, Model 6-850-00/ 01/02 (K010053) received a 510(k) decision of Substantially Equivalent on October 23, 2001, 288 days after the submission was received.
What is the product code of K010053?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.