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FDA 510(k)

GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE

K-Number: K971375 · 1997-10-31

ApplicantWilson Greatbatch Technologies, Inc.
Decision Date1997-10-31
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Wilson Greatbatch Technologies, Inc.. It received FDA 510(k) clearance on 1997-10-31 under 510(k) number K971375. 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 GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE?

GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE is a medical device that received FDA 510(k) clearance on 1997-10-31. The listed applicant is Wilson Greatbatch Technologies, Inc.. The 510(k) number is K971375.

When did GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE receive FDA 510(k) clearance?

GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE received FDA 510(k) clearance on 1997-10-31, under 510(k) number K971375.

Who is the listed applicant for GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE?

The FDA 510(k) record lists Wilson Greatbatch Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE?

The FDA product code for GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE is EOB.

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Other records listing Wilson Greatbatch Technologies, 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.

K971374GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPEK971377GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPEK972280GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPESK971781GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPESK970619GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLEK954649WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP

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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.

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