FDA 510(k)

GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE

K-Number: K971374 · 1998-05-13

ApplicantWilson Greatbatch Technologies, Inc.

Decision Date1998-05-13

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE 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 1998-05-13 under 510(k) number K971374. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE?

GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE is a medical device that received FDA 510(k) clearance on 1998-05-13. The listed applicant is Wilson Greatbatch Technologies, Inc.. The 510(k) number is K971374.

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

GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE received FDA 510(k) clearance on 1998-05-13, under 510(k) number K971374.

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

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 HYSTEROSCOPE?

The FDA product code for GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE is HIH.

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Other records listing Wilson Greatbatch Technologies, Inc. as applicant

K971377GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE K972280GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES K971781GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES K970619GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE K971375GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE K954649WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP

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Related Devices (Code: HIH)

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Official Source

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