Insite Filter & Tubing Set
FDA 510(k) K934928 · Andronic Devices, Ltd.
510(k) numberK934928
Submission
- Device name
- Insite Filter & Tubing Set
- Applicant
- Andronic Devices, Ltd.
Richmond, B.C. Canada V6v 2j2, CA - Received
- October 14, 1993
- Decision date
- May 26, 1994
- 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 |
|---|---|---|
| K940812 | Insight Electronic Alignment IndicatorKQX · Traditional | 11/21/1994SE |
| K934926 | Insite Model 20 & Model 15 InsufflatorsHIF · Traditional | 05/26/1994SE |
| K935381 | Kaps Positioning ArmFWZ · Traditional | 04/15/1994SE |
| K934124 | Autoquot Automated Aliquotting SystemJQW · Traditional | 04/13/1994SE |
| K936308 | Endex Endoscopic Positioning SystemFQO · Traditional | 03/31/1994SE |
| K932253 | Arthrobot Bi-Fold DrapeKKX · Traditional | 02/03/1994SE |
| K922626 | Adept Instrument Positioning AccessoryGAD · Traditional | 10/19/1992SE |
| K922625 | Adept Endoscopic PositionerGAD · Traditional | 10/19/1992SE |
| K911521 | Arthrobot(Tm) 96 (240 CM) Drape with 1 StrapKKX · Traditional | 08/02/1991SE |
| K911520 | Arthrobot(Tm) 75 (190 CM) General Purpose DrapeKKX · Traditional | 08/02/1991SE |
Questions and answers
When was Insite Filter & Tubing Set cleared by the FDA?
Insite Filter & Tubing Set (K934928) received a 510(k) decision of Substantially Equivalent on May 26, 1994, 224 days after the submission was received.
What is the product code of K934928?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.