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FDA 510(k)

STERILE DISPOSABLE ENDOCULAR PROBE

K-Number: K884456 · 1988-12-09

ApplicantBiophysic Medical, Inc.
Decision Date1988-12-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE ENDOCULAR PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Biophysic Medical, Inc.. It received FDA 510(k) clearance on 1988-12-09 under 510(k) number K884456. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE DISPOSABLE ENDOCULAR PROBE?

STERILE DISPOSABLE ENDOCULAR PROBE is a medical device that received FDA 510(k) clearance on 1988-12-09. The listed applicant is Biophysic Medical, Inc.. The 510(k) number is K884456.

When did STERILE DISPOSABLE ENDOCULAR PROBE receive FDA 510(k) clearance?

STERILE DISPOSABLE ENDOCULAR PROBE received FDA 510(k) clearance on 1988-12-09, under 510(k) number K884456.

Who is the listed applicant for STERILE DISPOSABLE ENDOCULAR PROBE?

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

What is the FDA product code for STERILE DISPOSABLE ENDOCULAR PROBE?

The FDA product code for STERILE DISPOSABLE ENDOCULAR PROBE is GEX. This falls under the Gastroenterology category.

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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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