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FDA 510(k)

URETERAL ILLUMINATOR

K-Number: K941506 · 1994-10-05

ApplicantApple Medical Corp.
Decision Date1994-10-05
Product CodeFCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETERAL ILLUMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Apple Medical Corp.. It received FDA 510(k) clearance on 1994-10-05 under 510(k) number K941506. The device is classified under product code FCS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URETERAL ILLUMINATOR?

URETERAL ILLUMINATOR is a medical device that received FDA 510(k) clearance on 1994-10-05. The listed applicant is Apple Medical Corp.. The 510(k) number is K941506.

When did URETERAL ILLUMINATOR receive FDA 510(k) clearance?

URETERAL ILLUMINATOR received FDA 510(k) clearance on 1994-10-05, under 510(k) number K941506.

Who is the listed applicant for URETERAL ILLUMINATOR?

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

What is the FDA product code for URETERAL ILLUMINATOR?

The FDA product code for URETERAL ILLUMINATOR is FCS.

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Other records listing Apple Medical Corp. 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.

K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158K050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORK041131APPLE MEDICAL OB MOBIUS ELASTIC RETRACTORK014005APPLE MEDICAL MOBIUS ELASTIC RETRACTORK000026APPLE MEDICAL ONE-TOUCH UTERINE SAMPLERK970788PNEUMO-MATIC INSUFFLATION NEEDLE

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Related Devices (Code: FCS)

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.

K061548STRYKER URETERAL ILLUMINATION SYSTEM IVStryker Corp.K982542STRYKER URETERAL ILLUMINATOR SYSTEM IIIStryker EndoscopyK943801URIGLOW TRANSILLUMINATING URETERIC STENT MODELRocket of London, Ltd.K945088GABRIEL URETERAL ILLUMINATOR SYSTEM IIGabriel Medical, Inc.K940019GABRIEL URETERAL ILLUMINATOR SYSTEMGabriel Medical, Inc.K923436ILLUMINATED URETERAL CATHETERCook Urological, Inc.

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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