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FDA 510(k)

OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM

K-Number: K091937 · 2009-09-09

ApplicantObp Corporation
Decision Date2009-09-09
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Obp Corporation. It received FDA 510(k) clearance on 2009-09-09 under 510(k) number K091937. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM?

OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM is a medical device that received FDA 510(k) clearance on 2009-09-09. The listed applicant is Obp Corporation. The 510(k) number is K091937.

When did OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM receive FDA 510(k) clearance?

OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM received FDA 510(k) clearance on 2009-09-09, under 510(k) number K091937.

Who is the listed applicant for OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM?

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

What is the FDA product code for OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM?

The FDA product code for OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM is HIB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Obp Corporation 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.

K121604ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT

Related Devices (Code: HIB)

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.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K072942MEDLINE DISPOSABLE VAGINAL SPECULUMMedline Industries, Inc.

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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