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FDA 510(k)

OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK

K-Number: K091838 · 2009-12-04

ApplicantObp Medical
Decision Date2009-12-04
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK is the device name listed in this FDA 510(k) record. The listed applicant is Obp Medical. It received FDA 510(k) clearance on 2009-12-04 under 510(k) number K091838. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK?

OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK is a medical device that received FDA 510(k) clearance on 2009-12-04. The listed applicant is Obp Medical. The 510(k) number is K091838.

When did OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK receive FDA 510(k) clearance?

OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK received FDA 510(k) clearance on 2009-12-04, under 510(k) number K091838.

Who is the listed applicant for OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK?

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

What is the FDA product code for OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK?

The FDA product code for OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK is HIH.

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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.

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