FDA 510(k)

PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE

K-Number: K083415 · 2009-06-05

Decision Date2009-06-05

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Peak Surgical, Inc.. It received FDA 510(k) clearance on 2009-06-05 under 510(k) number K083415. 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 PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE?

PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is Peak Surgical, Inc.. The 510(k) number is K083415.

When did PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE receive FDA 510(k) clearance?

PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE received FDA 510(k) clearance on 2009-06-05, under 510(k) number K083415.

Who is the listed applicant for PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE?

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

What is the FDA product code for PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE?

The FDA product code for PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE is GEI.

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Other records listing Peak Surgical, Inc. as applicant

K103775PEAK SUCTION COAGULATOR K102709PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE K102029PEAK PULSAR II GENERATOR MODEL PS100-102 K093695PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE K082786PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES K073057PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040

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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.