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FDA 510(k)

VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT

K-Number: K892693 · 1989-05-11

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-05-11
Product CodeKOH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K892693. 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 VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT?

VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K892693.

When did VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT receive FDA 510(k) clearance?

VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT received FDA 510(k) clearance on 1989-05-11, under 510(k) number K892693.

Who is the listed applicant for VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT?

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

What is the FDA product code for VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT?

The FDA product code for VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT is KOH.

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Other records listing Zinnanti Surgical Instruments, 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.

K925501NYLON COATED SPECULAK941458UTERINE MANIPULATOR/INJECTOR WITH SPRINGK941457UTERINE INJECTOR WITH SPRINGK925560ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODESK925957SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USEK925960FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE

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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.K891351NEWPORT LATERAL VAGINAL RETRACTORSimpson/Basye, 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.

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