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FDA 510(k)

NEWPORT CERVICAL MANIPULATOR

K-Number: K891350 · 1989-03-29

ApplicantSimpson/Basye, Inc.
Decision Date1989-03-29
Product CodeHDC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NEWPORT CERVICAL MANIPULATOR 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 1989-03-29 under 510(k) number K891350. The device is classified under product code HDC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEWPORT CERVICAL MANIPULATOR?

NEWPORT CERVICAL MANIPULATOR is a medical device that received FDA 510(k) clearance on 1989-03-29. The listed applicant is Simpson/Basye, Inc.. The 510(k) number is K891350.

When did NEWPORT CERVICAL MANIPULATOR receive FDA 510(k) clearance?

NEWPORT CERVICAL MANIPULATOR received FDA 510(k) clearance on 1989-03-29, under 510(k) number K891350.

Who is the listed applicant for NEWPORT CERVICAL MANIPULATOR?

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 NEWPORT CERVICAL MANIPULATOR?

The FDA product code for NEWPORT CERVICAL MANIPULATOR is HDC.

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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 HANDLEK891352MARLOW ANAL SPECULUMK891351NEWPORT LATERAL VAGINAL RETRACTORK891347REID ENDOCERVICAL SPREADERK891349CAMPION CERVICAL HOOKK891348CAMPION LASER FORCEPS

View all 12 devices →

Related Devices (Code: HDC)

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.

K223866Carevix™ Suction Cervical StabilizerAspivix SAK203820ASPIVIX v1.1 Cervical Suction TenaculumAspivix SAK082349JARIT HULKA UTERINE TENACULUM FORCEPSJ. Jamner Surgical Instruments, Inc.K073182GYN DISPOSABLES TENACULUM 356TGyn-Disposables, Inc.K062563FEMTEN CERVICAL TENACULUMFem Suite, LLCK060573BURBANK TENACULUMVascular Control Systems, 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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