Dymax Endovaginal Biopsy Guide
FDA 510(k) K894415 · Dymax Corp
510(k) numberK894415
Submission
- Device name
- Dymax Endovaginal Biopsy Guide
- Applicant
- Dymax Corp
Pittsburgh, PA, US - Received
- July 17, 1989
- Decision date
- October 25, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGL – Transducer, Ultrasonic, Obstetric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2960
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952031 | Ultrasound Transducer, Model US917HGL · Traditional | Advanced Medical Systems, Inc. | 07/18/1995SE |
| K923335 | Ultrasound Transucer, Model US915 -- ModificationHGL · Traditional | Advanced Medical Systems, Inc. | 07/22/1994SE |
| K924516 | OP3/VP4HGL · Traditional | Huntleigh Technology, Inc. | 06/28/1993SE |
| K903348 | Ultrasonic Pulsed Doppler Imaging SystemHGL · Traditional | Advanced Technology Laboratories, Inc. | 10/22/1990SE |
| K900966 | EUP-V12 5.0 MHZ Convex Array Transvaginal ProbeHGL · Traditional | Hitachi Medical Corp. of America | 09/12/1990SE |
| K903316 | Aloka UST-964P-5 Endovaginal TransducerHGL · Traditional | Ge Medical Systems Information Technologies | 08/22/1990SE |
| K901142 | Mer Multiplane Vaginal Probe (MVP)HGL · Traditional | Medical Equipment Resources | 08/22/1990SE |
| K900838 | Transvaginal Transducer AssemblyHGL · Traditional | Pie Medical Equipment B.V. | 05/23/1990SE |
| K895449 | Aloka Model SSD-650 Ultrasound Imaging SystemHGL · Traditional | Ge Medical Systems Information Technologies | 03/05/1990SE |
| K881263 | Model 500A Vascular Spectrum Analyzer W/DopplerHGL · Traditional | Multigon Industries, Inc. | 01/05/1990SE |
More from Multigon Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032135 | Site-Rite IV Ultrasound SystemIYO · Traditional | 07/21/2003SE |
| K993624 | Site-Rite 3 Ultrasound SystemIYO · Traditional | 11/10/1999SE |
| K931403 | Siterite Needle Guide (Modified)DQY · Traditional | 07/27/1993SE |
| K903158 | Siterite Needle GuideDQY · Traditional | 09/27/1990SE |
| K862127 | Dymax Personal ScannerIYO · Traditional | 12/11/1986SE |
| K850478 | Plus 1IYO · Traditional | 04/15/1985SE |
Questions and answers
When was Dymax Endovaginal Biopsy Guide cleared by the FDA?
Dymax Endovaginal Biopsy Guide (K894415) received a 510(k) decision of Substantially Equivalent on October 25, 1989, 100 days after the submission was received.
What is the product code of K894415?
The FDA product code is HGL – Transducer, Ultrasonic, Obstetric, a Class II (moderate risk) device regulated under 21 CFR 884.2960.