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FDA 510(k)

SPECULUM, VAGINAL, METAL FIBEROPTIC

K-Number: K864865 · 1987-01-09

ApplicantLuxtec Corp.
Decision Date1987-01-09
Product CodeHDG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPECULUM, VAGINAL, METAL FIBEROPTIC is the device name listed in this FDA 510(k) record. The listed applicant is Luxtec Corp.. It received FDA 510(k) clearance on 1987-01-09 under 510(k) number K864865. The device is classified under product code HDG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECULUM, VAGINAL, METAL FIBEROPTIC?

SPECULUM, VAGINAL, METAL FIBEROPTIC is a medical device that received FDA 510(k) clearance on 1987-01-09. The listed applicant is Luxtec Corp.. The 510(k) number is K864865.

When did SPECULUM, VAGINAL, METAL FIBEROPTIC receive FDA 510(k) clearance?

SPECULUM, VAGINAL, METAL FIBEROPTIC received FDA 510(k) clearance on 1987-01-09, under 510(k) number K864865.

Who is the listed applicant for SPECULUM, VAGINAL, METAL FIBEROPTIC?

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

What is the FDA product code for SPECULUM, VAGINAL, METAL FIBEROPTIC?

The FDA product code for SPECULUM, VAGINAL, METAL FIBEROPTIC is HDG.

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Other records listing Luxtec 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.

K973193LUXSCOPEK970642TENOSCOPEK970562TENOSNAREK950960REDDY ILLUMINATORK895248IMS5000 ILLUMINATED LOUPESK890716LUXTEC ACO SERIES 4000 LIGHT SOURCE

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Related Devices (Code: HDG)

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.

K771181VAGINAL ILLUMINATOR, MODEL 78570Welch Allyn, 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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