Scissors, Hook, Electrosurgical
FDA 510(k) K780955 · Kli
510(k) numberK780955
Submission
- Device name
- Scissors, Hook, Electrosurgical
- Applicant
- Kli
Mchenry, IL, US - Received
- June 9, 1978
- Decision date
- June 22, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K800822 | CO2 Cystoscopy/Urethroscopy ConsoleFAP · Traditional | 06/17/1980SE |
| K800913 | Gynecological Cysto/UrethroscopeFGC · Traditional | 05/14/1980SE |
| K781913 | Insuffalator LaparaoscopicHIF · Traditional | 12/04/1978SE |
| K781109 | Forceps, ElectrosurgicalHIN · Traditional | 09/14/1978SE |
| K781089 | One Incision Bi-Polar Electro. ForcepsHIN · Traditional | 07/17/1978SE |
| K780954 | Scissors, Hook, ElectrosurgicalKNF · Traditional | 06/22/1978SE |
| K772297 | Insufflator, Model G100 & 200HIF · Traditional | 01/05/1978SE |
| K772242 | Laparoscopy Console Model ViiiHET · Traditional | 12/20/1977SE |
| K772220 | Probe, Coagulation AccessoryKNF · Traditional | 12/13/1977SE |
| K772185 | Laparoscope W/Removable OpticsHET · Traditional | 11/30/1977SE |
Questions and answers
When was Scissors, Hook, Electrosurgical cleared by the FDA?
Scissors, Hook, Electrosurgical (K780955) received a 510(k) decision of Substantially Equivalent on June 22, 1978, 13 days after the submission was received.
What is the product code of K780955?
The FDA product code is KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.