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FDA 510(k)

THE OB-GYN CONCEPTS VAGINAL ASPIRATOR

K-Number: K863610 · 1987-01-07

ApplicantOb/Gyn Concepts, Ltd.
Decision Date1987-01-07
Product CodeKOH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THE OB-GYN CONCEPTS VAGINAL ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ob/Gyn Concepts, Ltd.. It received FDA 510(k) clearance on 1987-01-07 under 510(k) number K863610. The device is classified under product code KOH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE OB-GYN CONCEPTS VAGINAL ASPIRATOR?

THE OB-GYN CONCEPTS VAGINAL ASPIRATOR is a medical device that received FDA 510(k) clearance on 1987-01-07. The listed applicant is Ob/Gyn Concepts, Ltd.. The 510(k) number is K863610.

When did THE OB-GYN CONCEPTS VAGINAL ASPIRATOR receive FDA 510(k) clearance?

THE OB-GYN CONCEPTS VAGINAL ASPIRATOR received FDA 510(k) clearance on 1987-01-07, under 510(k) number K863610.

Who is the listed applicant for THE OB-GYN CONCEPTS VAGINAL ASPIRATOR?

The FDA 510(k) record lists Ob/Gyn Concepts, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE OB-GYN CONCEPTS VAGINAL ASPIRATOR?

The FDA product code for THE OB-GYN CONCEPTS VAGINAL ASPIRATOR is KOH.

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 Ob/Gyn Concepts, Ltd. 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.

K870528OVU-TRAC OVULATION TIMING KIT

Related Devices (Code: KOH)

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.

K000212KSEA CHARDONNES MORCELLATION KNIFEKARL STORZ Endoscopy-America, Inc.K921730C-SECTION PACKMedikmark, Inc.K921732MINOR LAP SETMedikmark, Inc.K892693VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTZinnanti Surgical Instruments, Inc.K891351NEWPORT LATERAL VAGINAL RETRACTORSimpson/Basye, Inc.K891035NEEDLE EXTENSIONSZinnanti Surgical Instruments, 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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