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FDA 510(k)

SURGICAL INSTRUMENT KIT, DISPOSABLE

K-Number: K923175 · 1993-06-17

ApplicantUlti-Med Intl., Inc.
Decision Date1993-06-17
Product CodeFMC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGICAL INSTRUMENT KIT, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Ulti-Med Intl., Inc.. It received FDA 510(k) clearance on 1993-06-17 under 510(k) number K923175. The device is classified under product code FMC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL INSTRUMENT KIT, DISPOSABLE?

SURGICAL INSTRUMENT KIT, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1993-06-17. The listed applicant is Ulti-Med Intl., Inc.. The 510(k) number is K923175.

When did SURGICAL INSTRUMENT KIT, DISPOSABLE receive FDA 510(k) clearance?

SURGICAL INSTRUMENT KIT, DISPOSABLE received FDA 510(k) clearance on 1993-06-17, under 510(k) number K923175.

Who is the listed applicant for SURGICAL INSTRUMENT KIT, DISPOSABLE?

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

What is the FDA product code for SURGICAL INSTRUMENT KIT, DISPOSABLE?

The FDA product code for SURGICAL INSTRUMENT KIT, DISPOSABLE is FMC.

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Other records listing Ulti-Med 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.

K103011ULTICARE SAFETY INSULIN SYRINGEK923176SURGICAL INSTRUMENT KIT, DISPOSABLEK920989SURGICAL INSTRUMENT KIT, DISPOSABLEK922828ULCER WOUND TRAYK914244STERILE CUSTOM SURGICAL KITSK914431ABSORBENT FIBER

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Related Devices (Code: FMC)

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.

K042618LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)La Glove (M) Sdn. Bhd.K014134POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)Supergrade Healthcare Products Sdn. Bhd.K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTAMexpo Intl., Inc.K932404NITRILE RUBBER POWDER-FREE EXAMINATION GLOVESafeskin Corp.K932405NITRILE RUBBER EXAMINATION GLOVES (POWERED)Safeskin Corp.K920649COMPASEPWilde-USA, Inc.

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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