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FDA 510(k)

HYSTALOG HSG CATHETER

K-Number: K000340 · 2000-04-19

ApplicantRocket Medical Plc
Decision Date2000-04-19
Product CodeHES
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HYSTALOG HSG CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Rocket Medical Plc. It received FDA 510(k) clearance on 2000-04-19 under 510(k) number K000340. 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 HYSTALOG HSG CATHETER?

HYSTALOG HSG CATHETER is a medical device that received FDA 510(k) clearance on 2000-04-19. The listed applicant is Rocket Medical Plc. The 510(k) number is K000340.

When did HYSTALOG HSG CATHETER receive FDA 510(k) clearance?

HYSTALOG HSG CATHETER received FDA 510(k) clearance on 2000-04-19, under 510(k) number K000340.

Who is the listed applicant for HYSTALOG HSG CATHETER?

The FDA 510(k) record lists Rocket Medical Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYSTALOG HSG CATHETER?

The FDA product code for HYSTALOG HSG CATHETER is HES.

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Other records listing Rocket Medical Plc 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.

K210509Rocket Platinum Cured CathterK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitK162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitK152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetK123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE BK052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

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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.

K903209MAXI-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/GynK890869BARD 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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