Imagyn Microlap Introducer
FDA 510(k) K943810 · Imagyn Medical, Inc.
510(k) numberK943810
Submission
- Device name
- Imagyn Microlap Introducer
- Applicant
- Imagyn Medical, Inc.
Laguna Niguel, CA, US - Received
- August 5, 1994
- Decision date
- January 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
|---|---|---|
| K972426 | Microspan Gold Hysteroscope and Microspan Hysteroscope SheathHIH · Traditional | 09/23/1997SE |
| K970750 | Microspan Insemination SystemMFD · Traditional | 05/05/1997SE |
| K971255 | Imagyn Expandable Laparoscopic IntroducerHET · Traditional | 04/21/1997SE |
| K965055 | Imagyn Microlap and Micro Lap-Gold LaparoscopesHET · Traditional | 03/06/1997SE |
| K963580 | Imagyn Falloposcopy SystemMKO · Traditional | 01/31/1997SE |
| K961688 | Microspan HysteroscopeHIH · Traditional | 10/15/1996SE |
| K961506 | Microspan Hysteroscope SheathHIH · Traditional | 07/03/1996SE |
| K952032 | Imagyn Hysteroscope SheathsHIH · Traditional | 10/31/1995SE |
| K951996 | Imagyn EndoscopeGCJ · Traditional | 09/01/1995SE |
| K951974 | Imagyn Endoscope SheathGCJ · Traditional | 08/28/1995SE |
Questions and answers
When was Imagyn Microlap Introducer cleared by the FDA?
Imagyn Microlap Introducer (K943810) received a 510(k) decision of Substantially Equivalent on January 26, 1995, 174 days after the submission was received.
What is the product code of K943810?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.