FDA 510(k)

GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES

K-Number: K972280 · 1997-12-11

ApplicantWilson Greatbatch Technologies, Inc.

Decision Date1997-12-11

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES 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 1997-12-11 under 510(k) number K972280. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES?

GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES is a medical device that received FDA 510(k) clearance on 1997-12-11. The listed applicant is Wilson Greatbatch Technologies, Inc.. The 510(k) number is K972280.

When did GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES receive FDA 510(k) clearance?

GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES received FDA 510(k) clearance on 1997-12-11, under 510(k) number K972280.

Who is the listed applicant for GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES?

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 LAPAROSCOPES AND OPERATING LAPAROSCOPES?

The FDA product code for GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES is GCJ.

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Other records listing Wilson Greatbatch Technologies, Inc. as applicant

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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.