Disposable, Filtered Insufflation Tubing, 92-900
FDA 510(k) K921963 · Sun Medical, Inc.
510(k) numberK921963
Submission
- Device name
- Disposable, Filtered Insufflation Tubing, 92-900
- Applicant
- Sun Medical, Inc.
Arlington, TX, US - Received
- April 27, 1992
- Decision date
- September 11, 1992
- 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 |
|---|---|---|
| K150511 | Coating MaterialEBI · Traditional | 05/27/2015SE |
| K143265 | Acrylic BlockEBI · Traditional | 04/14/2015SE |
| K911154 | Sun Medical Smoke/Fluid Evac Syst, Model SFE-200FYD · Traditional | 07/26/1991SE |
| K874948 | Sun Medical Smoke Evacuator SystemGEX · Traditional | 02/18/1988SE |
| K845006 | Sun Medical Laminaria Cervical DilatorHDY · Traditional | 05/01/1985SE |
Questions and answers
When was Disposable, Filtered Insufflation Tubing, 92-900 cleared by the FDA?
Disposable, Filtered Insufflation Tubing, 92-900 (K921963) received a 510(k) decision of Substantially Equivalent on September 11, 1992, 137 days after the submission was received.
What is the product code of K921963?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.