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FDA 510(k)

ENVISION G31 P.E. PAK

K-Number: K832424 · 1983-09-12

ApplicantEnvision, Inc.
Decision Date1983-09-12
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ENVISION G31 P.E. PAK is the device name listed in this FDA 510(k) record. The listed applicant is Envision, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832424. 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 ENVISION G31 P.E. PAK?

ENVISION G31 P.E. PAK is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Envision, Inc.. The 510(k) number is K832424.

When did ENVISION G31 P.E. PAK receive FDA 510(k) clearance?

ENVISION G31 P.E. PAK received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832424.

Who is the listed applicant for ENVISION G31 P.E. PAK?

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

What is the FDA product code for ENVISION G31 P.E. PAK?

The FDA product code for ENVISION G31 P.E. PAK 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 Envision, 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.

K832423ENVISION G21 I/A ENPAK

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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