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FDA 510(k)

OBSTETRIC CUP (MODIFICATION)

K-Number: K891465 · 1989-05-11

ApplicantGo Medical Industries Pty. , Ltd.
Decision Date1989-05-11
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OBSTETRIC CUP (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Go Medical Industries Pty. , Ltd.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K891465. The device is classified under product code HDB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBSTETRIC CUP (MODIFICATION)?

OBSTETRIC CUP (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Go Medical Industries Pty. , Ltd.. The 510(k) number is K891465.

When did OBSTETRIC CUP (MODIFICATION) receive FDA 510(k) clearance?

OBSTETRIC CUP (MODIFICATION) received FDA 510(k) clearance on 1989-05-11, under 510(k) number K891465.

Who is the listed applicant for OBSTETRIC CUP (MODIFICATION)?

The FDA 510(k) record lists Go Medical Industries Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBSTETRIC CUP (MODIFICATION)?

The FDA product code for OBSTETRIC CUP (MODIFICATION) is HDB.

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Other records listing Go Medical Industries Pty. , Ltd. 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.

K011055THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADSK002803THE O'NEIL STERILE FIELD URINARY CATHETER KITK000263GO MEDICAL BALLOON INFUSION SYSTEMK910007SPRINGFUSOR 10RK900336V SETK895594SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE

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Related Devices (Code: HDB)

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.

K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)Clinical Innovations, LLCK041579MEDELA SINGLE USE SILC CUP, MODEL 077.0791Medela AGK043614VACULINK, MODEL VCL 3000Medevco, Inc.K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300Fortune Medical Instrument Corp.K020447MITYVAC MERLIN, MODEL 10027Prism Enterprises, Inc.K013460SWIFT LOW PROFILE CUP (PRO CUP)Swift Delivery Products

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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