ST-610 Needlescope Sterilization Tray
FDA 510(k) K823297 · Medigroup
510(k) numberK823297
Submission
- Device name
- ST-610 Needlescope Sterilization Tray
- Applicant
- Medigroup
Mchenry, IL, US - Received
- November 5, 1982
- Decision date
- May 6, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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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 |
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| K120130 | Faller TrocarFJS · Traditional | 05/21/2012SE |
| K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560FJS · Traditional | 08/31/2007SESK |
| K070730 | Flex-Neck Arc CatheterFJS · Traditional | 07/03/2007SESK |
| K060897 | Embedding Tool, Model TE-1000FJS · Traditional | 07/18/2006SE |
| K031351 | Flex-Neck PD Catheter, InfantFJS · Traditional | 09/17/2003SE |
| K974570 | Peritoneal Dialysis Catheter ConnectorFKO · Traditional | 02/27/1998SE |
| K823294 | Medigroup LS-110 Light SourceHET · Traditional | 05/09/1983SE |
| K823295 | Medigroup 2.2MM Needlescope Cannula&HET · Traditional | 05/06/1983SE |
| K823293 | Medigroup LG-102 Light GuideHET · Traditional | 05/05/1983SE |
| K823390 | PC 201A Locking SleeveFKX · Traditional | 01/26/1983SE |
Questions and answers
When was ST-610 Needlescope Sterilization Tray cleared by the FDA?
ST-610 Needlescope Sterilization Tray (K823297) received a 510(k) decision of Substantially Equivalent on May 6, 1983, 182 days after the submission was received.
What is the product code of K823297?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.