Snowden-Pencer High Flow Insufflator, SP/88-9700
FDA 510(k) K920986 · Snowden-Pencer
510(k) numberK920986
Submission
- Device name
- Snowden-Pencer High Flow Insufflator, SP/88-9700
- Applicant
- Snowden-Pencer
Tucker, GA, US - Received
- March 2, 1992
- Decision date
- June 4, 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 |
|---|---|---|
| K030890 | SwitchbladeGEI · Traditional | 04/04/2003SE |
| K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…FBM · Traditional | 03/12/1996SE |
| K930666 | Reusable Laparoscopic Instruments W/ ElectrocauteryGEI · Traditional | 05/19/1994SE |
| K930667 | Reusable Laparoscopic InstrumentsGCJ · Traditional | 05/16/1994SE |
| K924148 | Diamond-Sharp(R) TrocarsHFI · Traditional | 02/28/1994SE |
| K924149 | Endo I/A ProbeGCJ · Traditional | 01/26/1993SE |
| K920985 | Snowden-Pencer Irrigation PumpHEI · Traditional | 06/09/1992SE |
| K913979 | Endo I/A Y SetHIF · Traditional | 11/27/1991SE |
| K913835 | Snowden-Pencer Insufflator Tubing SetHIF · Traditional | 11/07/1991SE |
| K861372 | Electrosurgical Cutting and Coagulation AccessoryGEI · Traditional | 06/19/1986SE |
Questions and answers
When was Snowden-Pencer High Flow Insufflator, SP/88-9700 cleared by the FDA?
Snowden-Pencer High Flow Insufflator, SP/88-9700 (K920986) received a 510(k) decision of Substantially Equivalent on June 4, 1992, 94 days after the submission was received.
What is the product code of K920986?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.