Jarit Surgical Instruments
FDA 510(k) K932456 · J. Jamner Surgical Instruments, Inc.
510(k) numberK932456
Submission
- Device name
- Jarit Surgical Instruments
- Applicant
- J. Jamner Surgical Instruments, Inc.
Great Neck, NY, US - Received
- May 21, 1993
- Decision date
- April 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K082349 | Jarit Hulka Uterine Tenaculum ForcepsHDC · Traditional | 11/21/2008SE |
| K944670 | Jarit Recommended Sinus InstrumentsEOB · Traditional | 02/02/1995SE |
| K944870 | Jarit Endoscopes, Models 600-600; 600-630; 600-650; and 600-680GCJ · Traditional | 11/02/1994SE |
| K941565 | Jarit Recommended Sinus InstrumentsEOB · Traditional | 05/16/1994SE |
| K933728 | Jarit Surgical Instruments: Catalog 615-330, 615-331, 615-334, 615-335, 615-338, 615-339GEI · Traditional | 02/23/1994SE |
| K931928 | Jarit Surgical InstrumentsGCJ · Traditional | 11/10/1993SE |
| K931959 | Jarit Surgical InstrumentsGEI · Traditional | 10/05/1993SE |
| K931878 | Jarit Endoscopes, 600-600; 600-630; 600-650; 680GCJ · Traditional | 08/19/1993SE |
| K771625 | Leiningeo Aortic Punch #310-395 & 397DWS · Traditional | 09/12/1977SE |
| K771624 | Cope Lung Forceps #305-218GEN · Traditional | 09/06/1977SE |
Questions and answers
When was Jarit Surgical Instruments cleared by the FDA?
Jarit Surgical Instruments (K932456) received a 510(k) decision of Substantially Equivalent on April 21, 1994, 335 days after the submission was received.
What is the product code of K932456?
The FDA product code is KNF – Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4160.