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FDA 510(k)

OPTHA PREP

K-Number: K871706 · 1987-05-18

ApplicantTreace Medical, Inc.
Decision Date1987-05-18
Product CodeHMT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTHA PREP is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1987-05-18 under 510(k) number K871706. The device is classified under product code HMT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTHA PREP?

OPTHA PREP is a medical device that received FDA 510(k) clearance on 1987-05-18. The listed applicant is Treace Medical, Inc.. The 510(k) number is K871706.

When did OPTHA PREP receive FDA 510(k) clearance?

OPTHA PREP received FDA 510(k) clearance on 1987-05-18, under 510(k) number K871706.

Who is the listed applicant for OPTHA PREP?

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

What is the FDA product code for OPTHA PREP?

The FDA product code for OPTHA PREP is HMT.

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Other records listing Treace Medical, Inc. 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

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Related Devices (Code: HMT)

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.

K945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEVisitec Co.K905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYAngiosystems, Inc.K872620SOLOS EYESITE DRAPESSolos OphthalmologyK854613SURGICAL DRAPES, OPHTHALMINCharles Atkins & Co.K831340DRAIN-R-DRAPE(EYESur-Tech, Inc.K830822EYE DRAPECooperVision, 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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