FDA 510(k)

NEWPORT LATERAL VAGINAL RETRACTOR

K-Number: K891351 · 1989-05-11

Decision Date1989-05-11

Product CodeKOH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

NEWPORT LATERAL VAGINAL RETRACTOR 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 1989-05-11 under 510(k) number K891351. 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 NEWPORT LATERAL VAGINAL RETRACTOR?

NEWPORT LATERAL VAGINAL RETRACTOR is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Simpson/Basye, Inc.. The 510(k) number is K891351.

When did NEWPORT LATERAL VAGINAL RETRACTOR receive FDA 510(k) clearance?

NEWPORT LATERAL VAGINAL RETRACTOR received FDA 510(k) clearance on 1989-05-11, under 510(k) number K891351.

Who is the listed applicant for NEWPORT LATERAL VAGINAL RETRACTOR?

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 LATERAL VAGINAL RETRACTOR?

The FDA product code for NEWPORT LATERAL VAGINAL RETRACTOR is KOH.

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Other records listing Simpson/Basye, Inc. as applicant

K926179SEDLACEK HANDLE K891352MARLOW ANAL SPECULUM K891347REID ENDOCERVICAL SPREADER K891349CAMPION CERVICAL HOOK K891350NEWPORT CERVICAL MANIPULATOR K891348CAMPION LASER FORCEPS

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Related Devices (Code: KOH)

K000212KSEA CHARDONNES MORCELLATION KNIFEKARL STORZ Endoscopy-America, Inc.K921730C-SECTION PACKMedikmark, Inc.K921732MINOR LAP SETMedikmark, Inc.K892693VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTZinnanti Surgical Instruments, Inc.K891035NEEDLE EXTENSIONSZinnanti Surgical Instruments, Inc.K891049ZEPPELIN SCISSORSZinnanti 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.