Verres Needle, Cannula for M820, Cannula W/Trumpet Valve for M 820
FDA 510(k) K971837 · CooperSurgical, Inc.
510(k) numberK971837
Submission
- Device name
- Verres Needle, Cannula for M820, Cannula W/Trumpet Valve for M 820
- Applicant
- CooperSurgical, Inc.
Shelton, CT, US - Received
- May 19, 1997
- Decision date
- August 6, 1997
- 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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| K191020 | G210 InviCell Plus with SignipHy pH monitoringPUB · Traditional | 01/14/2020SE |
| K191291 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Special | 06/12/2019SE |
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| K182959 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Traditional | 05/10/2019SE |
Questions and answers
When was Verres Needle, Cannula for M820, Cannula W/Trumpet Valve for M 820 cleared by the FDA?
Verres Needle, Cannula for M820, Cannula W/Trumpet Valve for M 820 (K971837) received a 510(k) decision of Substantially Equivalent on August 6, 1997, 79 days after the submission was received.
What is the product code of K971837?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.