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FDA 510(k)

UTERINE INJECTOR 2MM

K-Number: K873515 · 1987-09-29

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1987-09-29
Product CodeHES
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UTERINE INJECTOR 2MM 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 1987-09-29 under 510(k) number K873515. The device is classified under product code HES. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UTERINE INJECTOR 2MM?

UTERINE INJECTOR 2MM is a medical device that received FDA 510(k) clearance on 1987-09-29. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K873515.

When did UTERINE INJECTOR 2MM receive FDA 510(k) clearance?

UTERINE INJECTOR 2MM received FDA 510(k) clearance on 1987-09-29, under 510(k) number K873515.

Who is the listed applicant for UTERINE INJECTOR 2MM?

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 UTERINE INJECTOR 2MM?

The FDA product code for UTERINE INJECTOR 2MM is HES.

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Other records listing Zinnanti Surgical Instruments, Inc. as applicant

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Related Devices (Code: HES)

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.

K000340HYSTALOG HSG CATHETERRocket Medical PlcK903209MAXI-FLOW INSUFFLATOR TUBING SET W/FILTERAdler Instrument Co.K903208MAXI-FLOW INSUFFLATOR TUBING SETAdler Instrument Co.K904473KRONNER MANIPUJECTORUnimar, Inc.K901413CORE DISPOSABLE INSUFFLATION TUBINGCore Dynamics, Inc.K891290SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETERCook Ob/Gyn

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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