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FDA 510(k)

MARLOW ANAL SPECULUM

K-Number: K891352 · 1989-06-23

ApplicantSimpson/Basye, Inc.
Decision Date1989-06-23
Product CodeKOA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MARLOW ANAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Simpson/Basye, Inc.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K891352. The device is classified under product code KOA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARLOW ANAL SPECULUM?

MARLOW ANAL SPECULUM is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Simpson/Basye, Inc.. The 510(k) number is K891352.

When did MARLOW ANAL SPECULUM receive FDA 510(k) clearance?

MARLOW ANAL SPECULUM received FDA 510(k) clearance on 1989-06-23, under 510(k) number K891352.

Who is the listed applicant for MARLOW ANAL SPECULUM?

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

What is the FDA product code for MARLOW ANAL SPECULUM?

The FDA product code for MARLOW ANAL SPECULUM is KOA.

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Other records listing Simpson/Basye, Inc. 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.

K926179SEDLACEK HANDLEK891351NEWPORT LATERAL VAGINAL RETRACTORK891347REID ENDOCERVICAL SPREADERK891349CAMPION CERVICAL HOOKK891350NEWPORT CERVICAL MANIPULATORK891348CAMPION LASER FORCEPS

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Related Devices (Code: KOA)

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.

K182664FiXcisionAgency For Medical Innovations GmbHK950267URETHRAL SUTURE GUIDEApplied Medical ResourcesK932465LI VASECTOMYFemcare , Ltd.K921546VASOVASOSTOMY SETCook Urological, Inc.K931181VESITEC SUTURE PASSERVesitec Medical, Inc.K921304DDV LIGATORNorth American Medical, 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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