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FDA 510(k)

SINGLE SITE FLEXIBLE BLADELESS OBTURATOR

K-Number: K101671 · 2010-06-25

ApplicantTeleflexmedical, Inc.
Decision Date2010-06-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE SITE FLEXIBLE BLADELESS OBTURATOR is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2010-06-25 under 510(k) number K101671. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE SITE FLEXIBLE BLADELESS OBTURATOR?

SINGLE SITE FLEXIBLE BLADELESS OBTURATOR is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K101671.

When did SINGLE SITE FLEXIBLE BLADELESS OBTURATOR receive FDA 510(k) clearance?

SINGLE SITE FLEXIBLE BLADELESS OBTURATOR received FDA 510(k) clearance on 2010-06-25, under 510(k) number K101671.

Who is the listed applicant for SINGLE SITE FLEXIBLE BLADELESS OBTURATOR?

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

What is the FDA product code for SINGLE SITE FLEXIBLE BLADELESS OBTURATOR?

The FDA product code for SINGLE SITE FLEXIBLE BLADELESS OBTURATOR is GCJ.

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Related Devices (Code: GCJ)

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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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