Reflex(R) Esc
FDA 510(k) K924200 · Richard-Allan Medical Ind., Inc.
510(k) numberK924200
Submission
- Device name
- Reflex(R) Esc
- Applicant
- Richard-Allan Medical Ind., Inc.
Richland, MI, US - Received
- August 20, 1992
- Decision date
- February 22, 1994
- 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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|---|---|---|---|
| K250705 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Special | Gynesonics, Inc. | 04/02/2025SE |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional | Gynesonics, Inc. | 07/17/2024SE |
| K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)KNF · Special | Gynesonics, Inc. | 12/21/2023SE |
| K222304 | Sonata Transcervical Fibroid Ablation System 2.2KNF · Traditional | Gynesonics, Inc. | 11/08/2022SE |
| 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 |
| K103726 | Jarit Take-Apart Endoscopic InstrumentsKNF · Traditional | Integra LifeSciences Corporation | 02/08/2012SE |
More from Integra LifeSciences Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K931879 | Reflex HTRGCJ · Traditional | 03/24/1994SE |
| K926297 | Reflex EsiGEI · Traditional | 10/15/1993SE |
| K924761 | Sterile Endoscopic Dispos Trocars W/Safe ShieldGCJ · Traditional | 04/20/1993SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | 05/03/1990SE |
| K896262 | Titanium Ligating ClipsHBT · Traditional | 01/02/1990SE |
| K890314 | Protector (Surgical Instrument)MMK · Traditional | 02/27/1989SE |
| K873309 | Reflex(Tm) Ca-T Clip ApplierFZP · Traditional | 11/27/1987SE |
| K862404 | Reflex(Tm) Clip ApplierFZP · Traditional | 07/23/1986SE |
| K862223 | Micro Thin* ParaffinKEO · Traditional | 06/17/1986SE |
| K861890 | 100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2PPM · Traditional | 06/03/1986SE |
Questions and answers
When was Reflex(R) Esc cleared by the FDA?
Reflex(R) Esc (K924200) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 551 days after the submission was received.
What is the product code of K924200?
The FDA product code is KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.