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FDA 510(k)

STEPHENS DISPOSABLE SPECULUM

K-Number: K022836 · 2002-11-01

ApplicantStephens Instruments
Decision Date2002-11-01
Product CodeHNC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STEPHENS DISPOSABLE SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Stephens Instruments. It received FDA 510(k) clearance on 2002-11-01 under 510(k) number K022836. The device is classified under product code HNC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEPHENS DISPOSABLE SPECULUM?

STEPHENS DISPOSABLE SPECULUM is a medical device that received FDA 510(k) clearance on 2002-11-01. The listed applicant is Stephens Instruments. The 510(k) number is K022836.

When did STEPHENS DISPOSABLE SPECULUM receive FDA 510(k) clearance?

STEPHENS DISPOSABLE SPECULUM received FDA 510(k) clearance on 2002-11-01, under 510(k) number K022836.

Who is the listed applicant for STEPHENS DISPOSABLE SPECULUM?

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

What is the FDA product code for STEPHENS DISPOSABLE SPECULUM?

The FDA product code for STEPHENS DISPOSABLE SPECULUM is HNC.

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.

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Other records listing Stephens Instruments 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.

K022835STEPHENS DISPOSABLE FORCEPSK022842STEPHENS DISPOSABLE HOOKSK022840STEPHENS DISPOSABLE SCISSORSK022843GAYHEART CORNEAL EXCISION DEVICE

Related Devices (Code: HNC)

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.

K981235OCULOSTATLaser Center Dev. Corp.K964289EYE FIXATION SPECULUMEyefix, Inc.K863989THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)Keeler Instruments, Inc.K863664OPHTHALMIC SURGICAL SPECULUMMyocure, Inc.K843196VISITEC EYE SPECULUMVisitec Co.K830430EYELID SPECULUMDouglas C. Mckee & Co.

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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