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FDA 510(k)

PEAK SUCTION COAGULATOR

K-Number: K103775 · 2011-05-27

ApplicantPeak Surgical, Inc.
Decision Date2011-05-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PEAK SUCTION COAGULATOR 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 2011-05-27 under 510(k) number K103775. 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 SUCTION COAGULATOR?

PEAK SUCTION COAGULATOR is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Peak Surgical, Inc.. The 510(k) number is K103775.

When did PEAK SUCTION COAGULATOR receive FDA 510(k) clearance?

PEAK SUCTION COAGULATOR received FDA 510(k) clearance on 2011-05-27, under 510(k) number K103775.

Who is the listed applicant for PEAK SUCTION COAGULATOR?

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 SUCTION COAGULATOR?

The FDA product code for PEAK SUCTION COAGULATOR 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.

K102709PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICEK102029PEAK PULSAR II GENERATOR MODEL PS100-102K093695PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICEK083415PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICEK082786PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICESK073057PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040

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Related Devices (Code: GEI)

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.

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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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