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FDA 510(k)

BABISTICK

K-Number: K933365 · 1993-10-19

ApplicantGraphic Controls Corp.
Decision Date1993-10-19
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BABISTICK is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1993-10-19 under 510(k) number K933365. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABISTICK?

BABISTICK is a medical device that received FDA 510(k) clearance on 1993-10-19. The listed applicant is Graphic Controls Corp.. The 510(k) number is K933365.

When did BABISTICK receive FDA 510(k) clearance?

BABISTICK received FDA 510(k) clearance on 1993-10-19, under 510(k) number K933365.

Who is the listed applicant for BABISTICK?

The FDA 510(k) record lists Graphic Controls Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BABISTICK?

The FDA product code for BABISTICK is FMK.

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Other records listing Graphic Controls Corp. as applicant

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Related Devices (Code: FMK)

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.

K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.

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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