Sinuscope
FDA 510(k) K940317 · Stephen Chakoff, Inc.
510(k) numberK940317
Submission
- Device name
- Sinuscope
- Applicant
- Stephen Chakoff, Inc.
Miami, FL, US - Received
- January 24, 1994
- Decision date
- May 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K940316 | HysterscopeHIH · Traditional | 11/16/1995SE |
| K950753 | Chakoff Endoscopy (Camera Television Endoscopic Without AudioGCJ · Traditional | 05/15/1995SE |
| K951082 | Chakoff Endoscopy, Rigid EndoscopeGCJ · Traditional | 03/22/1995SE |
| K950748 | Chakoff Endoscopy (Fiber Optic Light Source Routine)GCJ · Traditional | 03/06/1995SE |
| K950747 | Chakoff Endoscopy (Light Source Endoscopic Xenon Arc.)GCJ · Traditional | 03/06/1995SE |
| K950746 | Chakoff Endoscopy (Set Laparoscopy)GCJ · Traditional | 03/06/1995SE |
| K950745 | Chakoff Endoscopy (Endoscope And/Or Accessories)GCJ · Traditional | 03/06/1995SE |
| K950744 | Chakoff Endoscopy (Ridgid Endoscope)GCJ · Traditional | 03/06/1995SE |
| K945421 | Chakoff EndoscopyFDG · Traditional | 12/23/1994SE |
| K945420 | Chakoff EndoscopyFCW · Traditional | 12/08/1994SE |
Questions and answers
When was Sinuscope cleared by the FDA?
Sinuscope (K940317) received a 510(k) decision of Substantially Equivalent on May 24, 1995, 485 days after the submission was received.
What is the product code of K940317?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.