Insufflator Tubing Kit W/Filter
FDA 510(k) K933094 · Inman Medical Corp.
510(k) numberK933094
Submission
- Device name
- Insufflator Tubing Kit W/Filter
- Applicant
- Inman Medical Corp.
Fort Worth, TX, US - Received
- June 24, 1993
- Decision date
- April 18, 1994
- 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 |
|---|---|---|
| K933171 | Inman Irrigation Tapered ProbeKYZ · Traditional | 04/29/1994SE |
| K933169 | Inman Endoscopic Blunt DissectorGCJ · Traditional | 04/19/1994SE |
| K933382 | Imc Cable/Wire CoverKKX · Traditional | 01/27/1994SE |
| K933774 | Imc Saline Wet DressingFRO · Traditional | 11/08/1993SN |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | 10/05/1993SE |
| K933170 | Inman Poole Tip Suction Probe W/Tubing KitGCY · Traditional | 09/16/1993SE |
| K932762 | 10.0MM Suction/Irrigation Probe & Tubing KitGCS · Traditional | 08/31/1993SE |
| K933371 | Imc Endoscopic Instrument HolderGCS · Traditional | 08/06/1993SE |
| K921291 | Inman Medical Packing StripFER · Traditional | 01/21/1993SE |
Questions and answers
When was Insufflator Tubing Kit W/Filter cleared by the FDA?
Insufflator Tubing Kit W/Filter (K933094) received a 510(k) decision of Substantially Equivalent on April 18, 1994, 298 days after the submission was received.
What is the product code of K933094?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.