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FDA 510(k)

LAPAROFLATOR 3000, STANDARD AND ELECTRONIC

K-Number: K875137 · 1988-03-02

ApplicantF.M. Wiest USA, Inc.
Decision Date1988-03-02
Product CodeHES
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROFLATOR 3000, STANDARD AND ELECTRONIC is the device name listed in this FDA 510(k) record. The listed applicant is F.M. Wiest USA, Inc.. It received FDA 510(k) clearance on 1988-03-02 under 510(k) number K875137. 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 LAPAROFLATOR 3000, STANDARD AND ELECTRONIC?

LAPAROFLATOR 3000, STANDARD AND ELECTRONIC is a medical device that received FDA 510(k) clearance on 1988-03-02. The listed applicant is F.M. Wiest USA, Inc.. The 510(k) number is K875137.

When did LAPAROFLATOR 3000, STANDARD AND ELECTRONIC receive FDA 510(k) clearance?

LAPAROFLATOR 3000, STANDARD AND ELECTRONIC received FDA 510(k) clearance on 1988-03-02, under 510(k) number K875137.

Who is the listed applicant for LAPAROFLATOR 3000, STANDARD AND ELECTRONIC?

The FDA 510(k) record lists F.M. Wiest USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROFLATOR 3000, STANDARD AND ELECTRONIC?

The FDA product code for LAPAROFLATOR 3000, STANDARD AND ELECTRONIC is HES.

Related Clinical Trials

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Other records listing F.M. Wiest USA, 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.

K921871HYSTEROMAT(TM) 3700K920574CAMSYS 6300K920575MERKUR 4000K915751URETEROMAT 4400K911844HYSTEROFLATOR 1500K912071SPACE(TM) 7500

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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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