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FDA 510(k)

UNIVERSAL PAC

K-Number: K834161 · 1983-12-28

ApplicantAmerican Surgical Co., Inc.
Decision Date1983-12-28
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL PAC is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Co., Inc.. It received FDA 510(k) clearance on 1983-12-28 under 510(k) number K834161. 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 UNIVERSAL PAC?

UNIVERSAL PAC is a medical device that received FDA 510(k) clearance on 1983-12-28. The listed applicant is American Surgical Co., Inc.. The 510(k) number is K834161.

When did UNIVERSAL PAC receive FDA 510(k) clearance?

UNIVERSAL PAC received FDA 510(k) clearance on 1983-12-28, under 510(k) number K834161.

Who is the listed applicant for UNIVERSAL PAC?

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

What is the FDA product code for UNIVERSAL PAC?

The FDA product code for UNIVERSAL PAC 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 American Surgical Co., 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.

K834160VITREONIC PLUSK834162VIT PACK841738AMER. SURGICAL CORP. EXTRA PLUS PAKK834159PHACOTRON PLUSK833697EXTRA SENSORY PAK-DISPOS. ACCESSK833617EXTRA PLUS TM

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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

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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