FDA 510(k)

OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF

K-Number: K092634 · 2009-12-01

ApplicantJiangmen City Xinhui Baisheng Medical Equipment CO

Decision Date2009-12-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF is the device name listed in this FDA 510(k) record. The listed applicant is Jiangmen City Xinhui Baisheng Medical Equipment CO. It received FDA 510(k) clearance on 2009-12-01 under 510(k) number K092634. 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 OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF?

OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF is a medical device that received FDA 510(k) clearance on 2009-12-01. The listed applicant is Jiangmen City Xinhui Baisheng Medical Equipment CO. The 510(k) number is K092634.

When did OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF receive FDA 510(k) clearance?

OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF received FDA 510(k) clearance on 2009-12-01, under 510(k) number K092634.

Who is the listed applicant for OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF?

The FDA 510(k) record lists Jiangmen City Xinhui Baisheng Medical Equipment CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF?

The FDA product code for OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF is GEI.

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Other records listing Jiangmen City Xinhui Baisheng Medical Equipment CO 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.