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FDA 510(k)

MODIFIED PK TP CONTROL

K-Number: K911266 · 1991-05-07

ApplicantOlympus Corp.
Decision Date1991-05-07
Product CodeGMT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED PK TP CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1991-05-07 under 510(k) number K911266. The device is classified under product code GMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED PK TP CONTROL?

MODIFIED PK TP CONTROL is a medical device that received FDA 510(k) clearance on 1991-05-07. The listed applicant is Olympus Corp.. The 510(k) number is K911266.

When did MODIFIED PK TP CONTROL receive FDA 510(k) clearance?

MODIFIED PK TP CONTROL received FDA 510(k) clearance on 1991-05-07, under 510(k) number K911266.

Who is the listed applicant for MODIFIED PK TP CONTROL?

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

What is the FDA product code for MODIFIED PK TP CONTROL?

The FDA product code for MODIFIED PK TP CONTROL is GMT.

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Other records listing Olympus 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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Related Devices (Code: GMT)

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.

K971502SERODIA TP-PAScimedx Tekfile ServicesK911640OLYMPUS PK TP(TM) SYSTEM, MODIFICATIONOlympus Corp.K905038OLYMPUS PK-TP ABSORBENT KITFujirebio America, Inc.K896410CELLOGNOST SYPHILIS HBehring Diagnostics, Inc.K893124OLYMPUS PK(TM) TPFujirebio Diagnostics,Inc.K791897BACTO-HATTSDifco Laboratories, 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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