Laparoscope
FDA 510(k) K903528 · Intramed Laboratories, Inc.
510(k) numberK903528
Submission
- Device name
- Laparoscope
- Applicant
- Intramed Laboratories, Inc.
San Diego, CA, US - Received
- August 6, 1990
- Decision date
- September 4, 1990
- 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
Other 510(k)s with product code HET
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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 |
| K210116 | Video Endoscopy System, 3D Video Endoscopy SystemHET · Traditional | Surgnova Healthcare Technologies (Zhejiang) Co.… | 10/13/2021SE |
| 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.
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| K953258 | Titanium Hemostatic ClipFZP · Traditional | 01/05/1996SE |
| K942457 | Graft Thrombectomy InstrumentsMCW · Traditional | 02/07/1995SE |
| K931792 | ArthroscopeHRH · Traditional | 06/13/1994SE |
| K925283 | ValvulotomeMGZ · Traditional | 02/10/1994SE |
| K934696 | AngioscopeLYK · Traditional | 01/18/1994SE |
| K922114 | Endoscopic Retrieval BasketFFL · Traditional | 08/03/1992SE |
| K914385 | Optical ValvulotomeMGZ · Traditional | 03/02/1992SE |
| K904465 | Flexible ArthroscopeHRX · Traditional | 12/20/1990SE |
| K902444 | Clearview(Tm) Angioscopic Irrigation PumpDQI · Traditional | 08/30/1990SE |
| K901010 | Flexible CholedochoscopeFBN · Traditional | 05/22/1990SE |
Questions and answers
When was Laparoscope cleared by the FDA?
Laparoscope (K903528) received a 510(k) decision of Substantially Equivalent on September 4, 1990, 29 days after the submission was received.
What is the product code of K903528?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.