Insufflator
FDA 510(k) K812200 · Reznik Instruments
510(k) numberK812200
Submission
- Device name
- Insufflator
- Applicant
- Reznik Instruments
Mchenry, IL, US - Received
- August 4, 1981
- Decision date
- September 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K812205 | ForcepGEN · Traditional | 10/26/1981SE |
| K812201 | Photographic EquipmentFEM · Traditional | 10/19/1981SE |
| K812206 | LaparoscopeHET · Traditional | 10/13/1981SE |
| K812204 | Uterine ManipulatorsKOH · Traditional | 10/13/1981SE |
| K812203 | Electrosurgical UnitGEI · Traditional | 10/13/1981SE |
| K812199 | Trocar & Trocar SleevesHET · Traditional | 10/13/1981SE |
| K812202 | Fiber Optic Light SourceHIH · Traditional | 09/29/1981SE |
| K812198 | Accessories(Probes, Suction Tubes, Etc.)GEI · Traditional | 09/11/1981SE |
Questions and answers
When was Insufflator cleared by the FDA?
Insufflator (K812200) received a 510(k) decision of Substantially Equivalent on September 29, 1981, 56 days after the submission was received.
What is the product code of K812200?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.