Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SINUSCOPE AND ACCESSORIES

K-Number: K981751 · 1998-08-13

ApplicantHenke Sass Wolf of America, Inc.
Decision Date1998-08-13
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SINUSCOPE AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Henke Sass Wolf of America, Inc.. It received FDA 510(k) clearance on 1998-08-13 under 510(k) number K981751. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINUSCOPE AND ACCESSORIES?

SINUSCOPE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1998-08-13. The listed applicant is Henke Sass Wolf of America, Inc.. The 510(k) number is K981751.

When did SINUSCOPE AND ACCESSORIES receive FDA 510(k) clearance?

SINUSCOPE AND ACCESSORIES received FDA 510(k) clearance on 1998-08-13, under 510(k) number K981751.

Who is the listed applicant for SINUSCOPE AND ACCESSORIES?

The FDA 510(k) record lists Henke Sass Wolf of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINUSCOPE AND ACCESSORIES?

The FDA product code for SINUSCOPE AND ACCESSORIES is EOB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Henke Sass Wolf of America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPEK050163HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPEK030572HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPEK013611HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPEK991563CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, CK983067FINE-JECT

View all 9 devices →

Related Devices (Code: EOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KGK261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑