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FDA 510(k)

LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS

K-Number: K864384 · 1986-11-19

ApplicantLuxtec Corp.
Decision Date1986-11-19
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS is the device name listed in this FDA 510(k) record. The listed applicant is Luxtec Corp.. It received FDA 510(k) clearance on 1986-11-19 under 510(k) number K864384. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS?

LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS is a medical device that received FDA 510(k) clearance on 1986-11-19. The listed applicant is Luxtec Corp.. The 510(k) number is K864384.

When did LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS receive FDA 510(k) clearance?

LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS received FDA 510(k) clearance on 1986-11-19, under 510(k) number K864384.

Who is the listed applicant for LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS?

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 LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS?

The FDA product code for LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS is GAD.

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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: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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