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FDA 510(k)

THE ELEVENTH FINGER

K-Number: K923835 · 1993-07-09

ApplicantGuardian Angel Products, Inc.
Decision Date1993-07-09
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE ELEVENTH FINGER is the device name listed in this FDA 510(k) record. The listed applicant is Guardian Angel Products, Inc.. It received FDA 510(k) clearance on 1993-07-09 under 510(k) number K923835. The device is classified under product code GDF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ELEVENTH FINGER?

THE ELEVENTH FINGER is a medical device that received FDA 510(k) clearance on 1993-07-09. The listed applicant is Guardian Angel Products, Inc.. The 510(k) number is K923835.

When did THE ELEVENTH FINGER receive FDA 510(k) clearance?

THE ELEVENTH FINGER received FDA 510(k) clearance on 1993-07-09, under 510(k) number K923835.

Who is the listed applicant for THE ELEVENTH FINGER?

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

What is the FDA product code for THE ELEVENTH FINGER?

The FDA product code for THE ELEVENTH FINGER is GDF.

Related Clinical Trials

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.

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Other records listing Guardian Angel Products, 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.

K030547MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBEK923840NEEDLE-GRABBERK910687GUARDIAN GEL, SURGEON'S GLOVING CREAMK896985ZAP-GUARD

Related Devices (Code: GDF)

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.

K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco HealthcK945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, Inc.

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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