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FDA 510(k)

NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM

K-Number: K881635 · 1988-07-01

ApplicantNoetix, Inc.
Decision Date1988-07-01
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Noetix, Inc.. It received FDA 510(k) clearance on 1988-07-01 under 510(k) number K881635. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM?

NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM is a medical device that received FDA 510(k) clearance on 1988-07-01. The listed applicant is Noetix, Inc.. The 510(k) number is K881635.

When did NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM receive FDA 510(k) clearance?

NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM received FDA 510(k) clearance on 1988-07-01, under 510(k) number K881635.

Who is the listed applicant for NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM?

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

What is the FDA product code for NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM?

The FDA product code for NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM is HQC.

Related Clinical Trials

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.

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Other records listing Noetix, 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.

K893992NOETIX, BIOPSY NEEDLEK871365CAPSULECTOMER CYSTOTOME

Related Devices (Code: HQC)

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.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

Official Source

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