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FDA 510(k)

NEEDLE EXTENSIONS

K-Number: K891035 · 1989-03-22

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-03-22
Product CodeKOH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NEEDLE EXTENSIONS 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 1989-03-22 under 510(k) number K891035. 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 NEEDLE EXTENSIONS?

NEEDLE EXTENSIONS is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K891035.

When did NEEDLE EXTENSIONS receive FDA 510(k) clearance?

NEEDLE EXTENSIONS received FDA 510(k) clearance on 1989-03-22, under 510(k) number K891035.

Who is the listed applicant for NEEDLE EXTENSIONS?

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 NEEDLE EXTENSIONS?

The FDA product code for NEEDLE EXTENSIONS 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.K892693VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTZinnanti Surgical Instruments, Inc.K891351NEWPORT LATERAL VAGINAL RETRACTORSimpson/Basye, 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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