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FDA 510(k)

MODIFIED DISPOSABLE FETAL VACUUM

K-Number: K915763 · 1992-03-18

ApplicantColumbia Medical & Surgical, Inc.
Decision Date1992-03-18
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFIED DISPOSABLE FETAL VACUUM is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Medical & Surgical, Inc.. It received FDA 510(k) clearance on 1992-03-18 under 510(k) number K915763. 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 MODIFIED DISPOSABLE FETAL VACUUM?

MODIFIED DISPOSABLE FETAL VACUUM is a medical device that received FDA 510(k) clearance on 1992-03-18. The listed applicant is Columbia Medical & Surgical, Inc.. The 510(k) number is K915763.

When did MODIFIED DISPOSABLE FETAL VACUUM receive FDA 510(k) clearance?

MODIFIED DISPOSABLE FETAL VACUUM received FDA 510(k) clearance on 1992-03-18, under 510(k) number K915763.

Who is the listed applicant for MODIFIED DISPOSABLE FETAL VACUUM?

The FDA 510(k) record lists Columbia Medical & Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED DISPOSABLE FETAL VACUUM?

The FDA product code for MODIFIED DISPOSABLE FETAL VACUUM is HDB.

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Other records listing Columbia Medical & Surgical, 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.

K942725CMI VELVET TOUCH VACUUM EXTRACTORK932128CMI E-Z FLO BULB P.N. 701K914552CMI VACUUM PUMP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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