Unisurge Disposable Trocar
FDA 510(k) K914923 · Unisurge, Inc.
510(k) numberK914923
Submission
- Device name
- Unisurge Disposable Trocar
- Applicant
- Unisurge, Inc.
Mountain View, CA, US - Received
- November 4, 1991
- Decision date
- September 21, 1992
- 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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| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | Schoelly Fiberoptic GmbH | 03/12/2021SE |
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| 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 |
|---|---|---|
| K943502 | UnigripGCJ · Traditional | 10/07/1994SE |
| K933720 | Instrument Actuating Device (Iad)GCJ · Traditional | 11/12/1993SE |
| K930605 | Applier, Surgical, ClipGCJ · Traditional | 10/08/1993SE |
| K930617 | Obgrip and Unitips(Tm)GCJ · Traditional | 08/11/1993SE |
| K932604 | Unigrip-Fh Surgical Handpiece/LaparoscopicGCJ · Traditional | 08/10/1993SE |
| K930809 | UnitipsGCJ · Traditional | 08/10/1993SE |
| K925917 | Unichannel(Tm Surgical GrasperGCJ · Traditional | 08/10/1993SE |
| K925882 | Unitips Surgical InstrumentsGCJ · Traditional | 08/10/1993SE |
| K926341 | Unitrocar(Tm) Reusable Surg Trocar/Resuse KitGCJ · Traditional | 05/17/1993SE |
| K926199 | Uniclip Surgical Clip ApplierGDO · Traditional | 04/20/1993SE |
Questions and answers
When was Unisurge Disposable Trocar cleared by the FDA?
Unisurge Disposable Trocar (K914923) received a 510(k) decision of Substantially Equivalent on September 21, 1992, 322 days after the submission was received.
What is the product code of K914923?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.