Jarit Take-Apart Endoscopic Instruments
FDA 510(k) K103726 · Integra LifeSciences Corporation
510(k) numberK103726
Submission
- Device name
- Jarit Take-Apart Endoscopic Instruments
- Applicant
- Integra LifeSciences Corporation
York, PA, US - Received
- December 22, 2010
- Decision date
- February 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4160
- Specialty
- Obstetrics/Gynecology
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| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)KNF · Special | Gynesonics, Inc. | 12/21/2023SE |
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| K211535 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Special | Gynesonics, Inc. | 06/17/2021SE |
| K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1KNF · Traditional | Gynesonics, Inc. | 05/04/2020SE |
| K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation SystemKNF · Traditional | Gynesonics, Inc. | 08/15/2018SE |
| K132135 | Lina Gold Loop HCKNF · Traditional | Lina Medical Aps | 01/31/2014SE |
| K121343 | Modulap LoopKNF · Traditional | Atc Technologies, Inc. | 06/14/2013SE |
| K092897 | Lap LoopKNF · Traditional | Medsys, S.A. | 02/01/2010SE |
More from Medsys, S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 10/08/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | 04/09/2025SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2023SE |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 08/22/2022SE |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Special | 07/15/2022SE |
| K210128 | INTEGRA Wound Matrix (Macro-Channels)KGN · Traditional | 10/08/2021SE |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…HRS · Traditional | 07/27/2021SE |
| K193346 | Codman Surgical Patties & StripsHBA · Traditional | 11/20/2020SE |
| K201507 | Cadence Total Ankle SystemHSN · Special | 06/29/2020SE |
Questions and answers
When was Jarit Take-Apart Endoscopic Instruments cleared by the FDA?
Jarit Take-Apart Endoscopic Instruments (K103726) received a 510(k) decision of Substantially Equivalent on February 8, 2012, 413 days after the submission was received.
What is the product code of K103726?
The FDA product code is KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.