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FDA 510(k)

ENDO-JUDGE

K-Number: K932591 · 1993-12-22

ApplicantSynergistic Medical Technologies, Inc.
Decision Date1993-12-22
Product CodeGAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDO-JUDGE is the device name listed in this FDA 510(k) record. The listed applicant is Synergistic Medical Technologies, Inc.. It received FDA 510(k) clearance on 1993-12-22 under 510(k) number K932591. 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 ENDO-JUDGE?

ENDO-JUDGE is a medical device that received FDA 510(k) clearance on 1993-12-22. The listed applicant is Synergistic Medical Technologies, Inc.. The 510(k) number is K932591.

When did ENDO-JUDGE receive FDA 510(k) clearance?

ENDO-JUDGE received FDA 510(k) clearance on 1993-12-22, under 510(k) number K932591.

Who is the listed applicant for ENDO-JUDGE?

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

What is the FDA product code for ENDO-JUDGE?

The FDA product code for ENDO-JUDGE 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.

K012199DIGICAPHumana USA, Inc.K980988AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)Axya Medical, 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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