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FDA 510(k)

DIGICAP

K-Number: K012199 · 2001-12-19

ApplicantHumana USA, Inc.
Decision Date2001-12-19
Product CodeGAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIGICAP is the device name listed in this FDA 510(k) record. The listed applicant is Humana USA, Inc.. It received FDA 510(k) clearance on 2001-12-19 under 510(k) number K012199. The device is classified under product code GAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGICAP?

DIGICAP is a medical device that received FDA 510(k) clearance on 2001-12-19. The listed applicant is Humana USA, Inc.. The 510(k) number is K012199.

When did DIGICAP receive FDA 510(k) clearance?

DIGICAP received FDA 510(k) clearance on 2001-12-19, under 510(k) number K012199.

Who is the listed applicant for DIGICAP?

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

What is the FDA product code for DIGICAP?

The FDA product code for DIGICAP is GAB.

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Related Devices (Code: GAB)

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.

K980988AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)Axya Medical, Inc.K932591ENDO-JUDGESynergistic Medical Technologies, Inc.K895681CONTRAST BACKGROUND MATERIALApplied Medical TechnologiesK863595COATED SUTURE NEEDLESharpoint, Inc.K831648ANCHOR BRAND SURGICAL NEEDLESAnchor Products Co.K812444RADIATION STERILIZATION FOR NEEDLE CNTRDevon Industries, 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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