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FDA 510(k)

OBSTETRICAL VACUUM CUP

K-Number: K911326 · 1991-08-14

ApplicantGesco Intl., Inc.
Decision Date1991-08-14
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OBSTETRICAL VACUUM CUP is the device name listed in this FDA 510(k) record. The listed applicant is Gesco Intl., Inc.. It received FDA 510(k) clearance on 1991-08-14 under 510(k) number K911326. 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 OBSTETRICAL VACUUM CUP?

OBSTETRICAL VACUUM CUP is a medical device that received FDA 510(k) clearance on 1991-08-14. The listed applicant is Gesco Intl., Inc.. The 510(k) number is K911326.

When did OBSTETRICAL VACUUM CUP receive FDA 510(k) clearance?

OBSTETRICAL VACUUM CUP received FDA 510(k) clearance on 1991-08-14, under 510(k) number K911326.

Who is the listed applicant for OBSTETRICAL VACUUM CUP?

The FDA 510(k) record lists Gesco Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBSTETRICAL VACUUM CUP?

The FDA product code for OBSTETRICAL VACUUM CUP is HDB.

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Other records listing Gesco Intl., 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.

K954422PER-Q-CATH MID-LINEK940953UMBILI-CATH-SK940870UMBILI-CATHK940952UMBILI-CATH-S-DLK941672URI-CATH CATHETERK941232THORA-CATH

View all 26 devices →

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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