Insufflator, Model G100 & 200
FDA 510(k) K772297 · Kli
510(k) numberK772297
Submission
- Device name
- Insufflator, Model G100 & 200
- Applicant
- Kli
Mchenry, IL, US - Received
- December 13, 1977
- Decision date
- January 5, 1978
- 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 |
|---|---|---|
| K800822 | CO2 Cystoscopy/Urethroscopy ConsoleFAP · Traditional | 06/17/1980SE |
| K800913 | Gynecological Cysto/UrethroscopeFGC · Traditional | 05/14/1980SE |
| K781913 | Insuffalator LaparaoscopicHIF · Traditional | 12/04/1978SE |
| K781109 | Forceps, ElectrosurgicalHIN · Traditional | 09/14/1978SE |
| K781089 | One Incision Bi-Polar Electro. ForcepsHIN · Traditional | 07/17/1978SE |
| K780955 | Scissors, Hook, ElectrosurgicalKNF · Traditional | 06/22/1978SE |
| K780954 | Scissors, Hook, ElectrosurgicalKNF · Traditional | 06/22/1978SE |
| K772242 | Laparoscopy Console Model ViiiHET · Traditional | 12/20/1977SE |
| K772220 | Probe, Coagulation AccessoryKNF · Traditional | 12/13/1977SE |
| K772185 | Laparoscope W/Removable OpticsHET · Traditional | 11/30/1977SE |
Questions and answers
When was Insufflator, Model G100 & 200 cleared by the FDA?
Insufflator, Model G100 & 200 (K772297) received a 510(k) decision of Substantially Equivalent on January 5, 1978, 23 days after the submission was received.
What is the product code of K772297?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.