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FDA 510(k)

THE ASSISTANT

K-Number: K952841 · 1995-08-18

ApplicantApple Medical Corp.
Decision Date1995-08-18
Product CodeFHA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE ASSISTANT 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 1995-08-18 under 510(k) number K952841. The device is classified under product code FHA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ASSISTANT?

THE ASSISTANT is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Apple Medical Corp.. The 510(k) number is K952841.

When did THE ASSISTANT receive FDA 510(k) clearance?

THE ASSISTANT received FDA 510(k) clearance on 1995-08-18, under 510(k) number K952841.

Who is the listed applicant for THE ASSISTANT?

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 THE ASSISTANT?

The FDA product code for THE ASSISTANT is FHA.

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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: FHA)

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.

K974040C3 EXTERNAL MALE BLADDER CONTROL DEVICETimm Research Co.K971992UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)Uromed Corp.K970308MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCEMentor Urology, Inc.K964580CAP-AID (IMPROVED)Nebel, Inc.K955810U-TEXLaborie Medical Technologies, Ltd.K954959CAP-AIDNebl, 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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