Transvaginal Hydro Laparoscopy (THL) System
FDA 510(k) K992544 · Circon Corp.
510(k) numberK992544
Submission
- Device name
- Transvaginal Hydro Laparoscopy (THL) System
- Applicant
- Circon Corp.
Santa Barbara, CA, US - Received
- July 30, 1999
- Decision date
- October 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEX – Colposcope (And Colpomicroscope)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1630
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K233043 | Smart Scope® CXHEX · Traditional | Periwinkle Technologies Pvt., Ltd. | 06/14/2024SE |
| K190187 | Gynescope SystemHEX · Traditional | Illumigyn , Ltd. | 05/08/2019SE |
| K182764 | Biop Digital ColposcopeHEX · Traditional | Biop Medical , Ltd. | 11/27/2018SE |
| K181034 | Pocket Colposcope SystemHEX · Traditional | Hadleigh Health Technologies, LLC | 09/21/2018SE |
| K170446 | LT-300 SD Digital Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 05/21/2017SE |
| K161871 | EVA (Enhanced Visual Assessment) SystemHEX · Traditional | Mobileodt , Ltd. | 12/19/2016SE |
| K160341 | Colposcope SystemHEX · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 09/14/2016SE |
| K160380 | LT-300 HDHEX · Traditional | Lutech Industries, Inc. | 05/13/2016SE |
| K151878 | Video ColposcopeHEX · Traditional | Edan Instruments, Inc. | 12/01/2015SE |
| K143119 | LT-300 Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 12/18/2014SE |
More from Lutech Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992126 | Circon Surgiflex Wave Tsunami Suction-Irrigation SystemGCX · Traditional | 08/03/1999SE |
| K981611 | Snap-N-Peel IntroducersKNY · Traditional | 07/30/1998SE |
| K980972 | Rigid Culdoscope and AccessoriesHEW · Traditional | 06/12/1998SE |
| K973820 | USA Elite System Vaportrode Vaporization Electrode and Vaportome Resection ElectrodeFAS · Traditional | 05/12/1998SE |
| K964594 | Vaportrode Vaporization Electrode -Grooved/Fluted/Spiked(Gve-B,Gve-F,Gve-S) & Vaportomme…KNF · Traditional | 08/15/1997SE |
Questions and answers
When was Transvaginal Hydro Laparoscopy (THL) System cleared by the FDA?
Transvaginal Hydro Laparoscopy (THL) System (K992544) received a 510(k) decision of Substantially Equivalent on October 26, 1999, 88 days after the submission was received.
What is the product code of K992544?
The FDA product code is HEX – Colposcope (And Colpomicroscope), a Class II (moderate risk) device regulated under 21 CFR 884.1630.