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FDA 510(k)

HOUTS HYSTERECTOMY DRAIN

K-Number: K894220 · 1989-08-24

ApplicantHelix Medical, Inc.
Decision Date1989-08-24
Product CodeGBW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HOUTS HYSTERECTOMY DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Helix Medical, Inc.. It received FDA 510(k) clearance on 1989-08-24 under 510(k) number K894220. The device is classified under product code GBW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOUTS HYSTERECTOMY DRAIN?

HOUTS HYSTERECTOMY DRAIN is a medical device that received FDA 510(k) clearance on 1989-08-24. The listed applicant is Helix Medical, Inc.. The 510(k) number is K894220.

When did HOUTS HYSTERECTOMY DRAIN receive FDA 510(k) clearance?

HOUTS HYSTERECTOMY DRAIN received FDA 510(k) clearance on 1989-08-24, under 510(k) number K894220.

Who is the listed applicant for HOUTS HYSTERECTOMY DRAIN?

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

What is the FDA product code for HOUTS HYSTERECTOMY DRAIN?

The FDA product code for HOUTS HYSTERECTOMY DRAIN is GBW.

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Related Devices (Code: GBW)

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.

K992907INTRADUCERTaut, Inc.K992904MINI-PORTTaut, Inc.K972112INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450Taut, Inc.K961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAINSil-Med Corp.K960426MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETERMedical Components, Inc.K942709MEDIASTINAL SILICONE DRAINSSil-Med Corp.

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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