Aspen Surgical Systems Insufflation Tubing Set with Filter
FDA 510(k) K943954 · Conmedcorp
510(k) numberK943954
Submission
- Device name
- Aspen Surgical Systems Insufflation Tubing Set with Filter
- Applicant
- Conmedcorp
Dayton, OH, US - Received
- August 15, 1994
- Decision date
- November 15, 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 |
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| K021079 | Abcsnare Electrosurgical Probe for Flexible Endoscopes, Model 1336XXGEI · Traditional | 07/01/2002SE |
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| K020186 | Conmed System 5000 EsuGEI · Traditional | 04/12/2002SE |
| K020135 | Conmed System 2000 Electrosurgical Generator, Ref: 60-8002; Conmed Esu Cart, Ref: 60-6120GEI · Traditional | 04/12/2002SE |
Questions and answers
When was Aspen Surgical Systems Insufflation Tubing Set with Filter cleared by the FDA?
Aspen Surgical Systems Insufflation Tubing Set with Filter (K943954) received a 510(k) decision of Substantially Equivalent on November 15, 1994, 92 days after the submission was received.
What is the product code of K943954?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.