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FDA 510(k)

MONOCRYSTANT PH/LES CATHETER, MODIFICATION

K-Number: K914793 · 1993-12-13

ApplicantSynectics-Dantec
Decision Date1993-12-13
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MONOCRYSTANT PH/LES CATHETER, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Synectics-Dantec. It received FDA 510(k) clearance on 1993-12-13 under 510(k) number K914793. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOCRYSTANT PH/LES CATHETER, MODIFICATION?

MONOCRYSTANT PH/LES CATHETER, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-12-13. The listed applicant is Synectics-Dantec. The 510(k) number is K914793.

When did MONOCRYSTANT PH/LES CATHETER, MODIFICATION receive FDA 510(k) clearance?

MONOCRYSTANT PH/LES CATHETER, MODIFICATION received FDA 510(k) clearance on 1993-12-13, under 510(k) number K914793.

Who is the listed applicant for MONOCRYSTANT PH/LES CATHETER, MODIFICATION?

The FDA 510(k) record lists Synectics-Dantec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOCRYSTANT PH/LES CATHETER, MODIFICATION?

The FDA product code for MONOCRYSTANT PH/LES CATHETER, MODIFICATION is KLA.

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Other records listing Synectics-Dantec 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.

K961346PH ANALYSIS MODULEK925405ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.K924875MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONSK924383SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM UROK913817MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATIONK914624PH METER, MODIFICATION

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Related Devices (Code: KLA)

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.

K242666Fecobionics Anorectal SystemGi Bionics, LLCK242304REDNeuraxis, Inc.K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp.K180135THD Anopress with THD SensyProbeThd SpaK161785THD ANOPRESSThd SpaK120088MCOMPASS ANORECTAL MANOMETRY SYSTEMMedspira, LLC

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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