Aqua Purator-Biotherm, Wisap Model # 1608
FDA 510(k) K982518 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
510(k) numberK982518
Submission
- Device name
- Aqua Purator-Biotherm, Wisap Model # 1608
- Applicant
- Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
Sauerlach, DE - Received
- July 20, 1998
- Decision date
- January 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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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| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5HET · Traditional | Olympus Medical Systems Corp. | 09/17/2021SE |
| 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 |
|---|---|---|
| K031014 | Hi-Flo Therme Pneu 45, Wisap #7083, 7083VHIF · Traditional | 06/27/2003SE |
| K011510 | Multi Hi-Flo Pneu, Wisap #7080HIF · Traditional | 04/02/2002SE |
| K992513 | Therme-Pneu Computer, Wisap #7070C, #7070CF, #7070CM, #7070CMFHET · Traditional | 03/17/2000SE |
| K992481 | CO2-OP-PNEU Computer, Wisap #7050C, #7050CF, #7050CMFHET · Traditional | 03/17/2000SE |
| K990662 | Disposable Heating Tubing Set #7642HSESHIF · Traditional | 09/24/1999SE |
| K982515 | Power-Drive, Wisap Model #7688PD/7688PD1HET · Traditional | 01/19/1999SE |
| K960640 | S*E*M*M* Set for Moto Drive Wisap #7689 SSM (Modification)HET · Traditional | 02/14/1997SE |
| K952508 | Flow-Therme, Wisap #7642HET · Traditional | 08/25/1995SE |
Questions and answers
When was Aqua Purator-Biotherm, Wisap Model # 1608 cleared by the FDA?
Aqua Purator-Biotherm, Wisap Model # 1608 (K982518) received a 510(k) decision of Substantially Equivalent on January 14, 1999, 178 days after the submission was received.
What is the product code of K982518?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.