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FDA 510(k)

PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES

K-Number: K082786 · 2008-12-03

ApplicantPeak Surgical, Inc.
Decision Date2008-12-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES 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 2008-12-03 under 510(k) number K082786. 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 PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES?

PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES is a medical device that received FDA 510(k) clearance on 2008-12-03. The listed applicant is Peak Surgical, Inc.. The 510(k) number is K082786.

When did PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES receive FDA 510(k) clearance?

PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES received FDA 510(k) clearance on 2008-12-03, under 510(k) number K082786.

Who is the listed applicant for PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES?

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 PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES?

The FDA product code for PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES is GEI.

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Other records listing Peak Surgical, 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.

K103775PEAK SUCTION COAGULATORK102709PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICEK102029PEAK PULSAR II GENERATOR MODEL PS100-102K093695PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICEK083415PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICEK073057PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040

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Related Devices (Code: GEI)

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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.

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