Sinuscope and Accessories
FDA 510(k) K981751 · Henke Sass Wolf of America, Inc.
510(k) numberK981751
Submission
- Device name
- Sinuscope and Accessories
- Applicant
- Henke Sass Wolf of America, Inc.
Southbridge, MA, US - Received
- May 18, 1998
- Decision date
- August 13, 1998
- 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).
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| 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 |
|---|---|---|
| K080560 | Henke Sass Wolf of America ArthroscopeHRX · Traditional | 03/18/2008SE |
| K050163 | Henke Sass Wolf of America Bariatric LaparoscopeGCJ · Traditional | 03/24/2005SE |
| K030572 | Henke Sass Wolf of America NasopharyngoscopeEOB · Traditional | 04/01/2003SE |
| K013611 | Henke Sass Wolf Saphenous Vein LaparoscopeGCJ · Traditional | 02/01/2002SE |
| K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation…HIH · Traditional | 10/13/1999SE |
| K983067 | Fine-JectFMI · Traditional | 10/30/1998SE |
| K962075 | HSW GmbH ArthroscopeHRX · Traditional | 01/17/1997SE |
| K941541 | HSV Laparoscopy SetGCJ · Traditional | 05/16/1994SE |
Questions and answers
When was Sinuscope and Accessories cleared by the FDA?
Sinuscope and Accessories (K981751) received a 510(k) decision of Substantially Equivalent on August 13, 1998, 87 days after the submission was received.
What is the product code of K981751?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.