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FDA 510(k)

SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER

K-Number: K891290 · 1989-05-23

ApplicantCook Ob/Gyn
Decision Date1989-05-23
Product CodeHES
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1989-05-23 under 510(k) number K891290. 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 SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER?

SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER is a medical device that received FDA 510(k) clearance on 1989-05-23. The listed applicant is Cook Ob/Gyn. The 510(k) number is K891290.

When did SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER receive FDA 510(k) clearance?

SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER received FDA 510(k) clearance on 1989-05-23, under 510(k) number K891290.

Who is the listed applicant for SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER?

The FDA product code for SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER is HES.

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Other records listing Cook Ob/Gyn 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.

K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500K030441SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KITK023850SYDNEY IVF EMBRYO BIOPSY MEDIUMK013597TAMPONADE UTERINE BALLOON CATHETER SETK002385COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,K002383COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT

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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.K890869BARD HYSTEROSALPINGOGRAPHY CATHETERSC.R. Bard, 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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