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FDA 510(k)

PEARCE CORNEAL TREPHINE

K-Number: K812723 · 1981-10-13

ApplicantVisitec Co.
Decision Date1981-10-13
Product CodeHRH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PEARCE CORNEAL TREPHINE is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1981-10-13 under 510(k) number K812723. The device is classified under product code HRH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEARCE CORNEAL TREPHINE?

PEARCE CORNEAL TREPHINE is a medical device that received FDA 510(k) clearance on 1981-10-13. The listed applicant is Visitec Co.. The 510(k) number is K812723.

When did PEARCE CORNEAL TREPHINE receive FDA 510(k) clearance?

PEARCE CORNEAL TREPHINE received FDA 510(k) clearance on 1981-10-13, under 510(k) number K812723.

Who is the listed applicant for PEARCE CORNEAL TREPHINE?

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

What is the FDA product code for PEARCE CORNEAL TREPHINE?

The FDA product code for PEARCE CORNEAL TREPHINE is HRH.

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Other records listing Visitec Co. 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.

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUGK945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEK945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSK942234VISITEC PRECISE-POINTK934269FIBEROPTIC ILLUMINATED INSTRUMENTS

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Related Devices (Code: HRH)

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.

K022843GAYHEART CORNEAL EXCISION DEVICEStephens InstrumentsK931792ARTHROSCOPEIntramed Laboratories, Inc.K873918HEAD & CHIN RESTSRichmond Products, Inc.K864520BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRONPrecision Instruments, Inc.K862524DEKNATEL (R) TREPHINEDeknatel, Inc.K861825CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADEStorz Instrument Co.

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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