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FDA 510(k)

SURGITEK NPT MONITOR

K-Number: K875333 · 1988-04-13

ApplicantSurgitek
Decision Date1988-04-13
Product CodeLIL
DecisionSubstantially Equivalent

Device Summary

SURGITEK NPT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K875333. The device is classified under product code LIL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK NPT MONITOR?

SURGITEK NPT MONITOR is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Surgitek. The 510(k) number is K875333.

When did SURGITEK NPT MONITOR receive FDA 510(k) clearance?

SURGITEK NPT MONITOR received FDA 510(k) clearance on 1988-04-13, under 510(k) number K875333.

Who is the listed applicant for SURGITEK NPT MONITOR?

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

What is the FDA product code for SURGITEK NPT MONITOR?

The FDA product code for SURGITEK NPT MONITOR is LIL.

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Other records listing Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933260HELICAL STONE/FLATWIRE STONE BASKETSK933261GRASPING FORCEPS

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Related Devices (Code: LIL)

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.

K061676RIGIDOMETER, MODEL DIR-4UUroan 21K062042PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)Plethora SolutionsK052929PREFTEST PROFESSIONAL SUITELimestone Technologies, Inc.K033126MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEMBehavioral Technology, Inc.K000194DIGITAL INFLECTION RIGIDOMETER (DIR)Uroan Xxi ElectromedicinaK991479VISER PENILE TUMESCENCE MONITORLaborie Medical Tech Corp.

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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