FDA 510(k)

DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS

K-Number: K110924 · 2011-12-07

Decision Date2011-12-07

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Synergetics, Inc.. It received FDA 510(k) clearance on 2011-12-07 under 510(k) number K110924. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS?

DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS is a medical device that received FDA 510(k) clearance on 2011-12-07. The listed applicant is Synergetics, Inc.. The 510(k) number is K110924.

When did DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS receive FDA 510(k) clearance?

DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS received FDA 510(k) clearance on 2011-12-07, under 510(k) number K110924.

Who is the listed applicant for DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS?

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

What is the FDA product code for DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS?

The FDA product code for DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS is GEI.

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Other records listing Synergetics, 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.