FDA 510(k)

SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE

K-Number: K082568 · 2008-11-17

Decision Date2008-11-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical. It received FDA 510(k) clearance on 2008-11-17 under 510(k) number K082568. 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 SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE?

SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE is a medical device that received FDA 510(k) clearance on 2008-11-17. The listed applicant is Bovie Medical. The 510(k) number is K082568.

When did SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE receive FDA 510(k) clearance?

SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE received FDA 510(k) clearance on 2008-11-17, under 510(k) number K082568.

Who is the listed applicant for SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE?

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

What is the FDA product code for SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE?

The FDA product code for SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE is GEI.

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Other records listing Bovie Medical as applicant

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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.