Jarit Recommended Sinus Instruments
FDA 510(k) K941565 · J. Jamner Surgical Instruments, Inc.
510(k) numberK941565
Submission
- Device name
- Jarit Recommended Sinus Instruments
- Applicant
- J. Jamner Surgical Instruments, Inc.
Hawthorne, NY, US - Received
- April 1, 1994
- Decision date
- May 16, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code EOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261544 | Hydro Irrigation SystemEOB · Traditional | Stryker Instruments | 06/17/2026SE |
| K254133 | ENTity USB Videoscope SystemEOB · Traditional | Optim, LLC | 05/14/2026SE |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic…EOB · Traditional | Zhuhai Wesee Meditech Co., Ltd. | 03/25/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | Olympus Medical Systems Corporation | 03/20/2026SE |
| K241731 | Outlook Surgical Versa One System (8900139)EOB · Traditional | Resnent, LLC | 08/11/2025SE |
| K243639 | Portare System (FA-001)EOB · Traditional | Grumpy Innovation, Inc. | 06/05/2025SE |
| K243380 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)EOB · Traditional | Olympus Medical Systems Corporation | 03/03/2025SE |
| K234096 | MonoStereoEOB · Traditional | Medicaltek Co., Ltd. | 09/19/2024SE |
| K232435 | Rhinolaryngoscope systemEOB · Traditional | Shenzhen HugeMed Medical Technical Development… | 04/26/2024SE |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)EOB · Traditional | Atmos Medizintechnik GmbH & Co. KG | 08/03/2023SE |
More from Atmos Medizintechnik GmbH & Co. KG
| 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 |
| K932456 | Jarit Surgical InstrumentsKNF · Traditional | 04/21/1994SE |
| 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 Recommended Sinus Instruments cleared by the FDA?
Jarit Recommended Sinus Instruments (K941565) received a 510(k) decision of Substantially Equivalent on May 16, 1994, 45 days after the submission was received.
What is the product code of K941565?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.