Laparoscope W/Removable Optics
FDA 510(k) K772185 · Kli
510(k) numberK772185
Submission
- Device name
- Laparoscope W/Removable Optics
- Applicant
- Kli
Walker, MI, US - Received
- November 25, 1977
- Decision date
- November 30, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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| K250939 | SIRIUS Endoscope System (PR-SI-1230)HET · Traditional | Precision Robotics (Hong Kong) Limited | 08/29/2025SE |
| K243821 | i-CutHET · Traditional | A.M.I. Agency For Medical Innovations GmbH | 04/25/2025SE |
| K221642 | SIRIUS Endoscope SystemHET · Traditional | Precision Robotics (Hong Kong) Limited | 12/12/2022SE |
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| K210104 | SurroundScope SystemHET · Traditional | 270surgical , Ltd. | 07/08/2021SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | Schoelly Fiberoptic GmbH | 03/12/2021SE |
| K200216 | 4K UHD Camera SystemHET · Traditional | Scivita Medical Technology Co., Ltd. | 08/21/2020SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
More from 270surgical , Ltd.
| 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 |
| K772297 | Insufflator, Model G100 & 200HIF · Traditional | 01/05/1978SE |
| K772242 | Laparoscopy Console Model ViiiHET · Traditional | 12/20/1977SE |
| K772220 | Probe, Coagulation AccessoryKNF · Traditional | 12/13/1977SE |
Questions and answers
When was Laparoscope W/Removable Optics cleared by the FDA?
Laparoscope W/Removable Optics (K772185) received a 510(k) decision of Substantially Equivalent on November 30, 1977, 5 days after the submission was received.
What is the product code of K772185?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.