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FDA 510(k)

FRIGITRONICS ACC-1000 CAPSULE CUTTER

K-Number: K872362 · 1987-07-27

ApplicantFrigitronics of Connecticut, Inc.
Decision Date1987-07-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FRIGITRONICS ACC-1000 CAPSULE CUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Frigitronics of Connecticut, Inc.. It received FDA 510(k) clearance on 1987-07-27 under 510(k) number K872362. 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 FRIGITRONICS ACC-1000 CAPSULE CUTTER?

FRIGITRONICS ACC-1000 CAPSULE CUTTER is a medical device that received FDA 510(k) clearance on 1987-07-27. The listed applicant is Frigitronics of Connecticut, Inc.. The 510(k) number is K872362.

When did FRIGITRONICS ACC-1000 CAPSULE CUTTER receive FDA 510(k) clearance?

FRIGITRONICS ACC-1000 CAPSULE CUTTER received FDA 510(k) clearance on 1987-07-27, under 510(k) number K872362.

Who is the listed applicant for FRIGITRONICS ACC-1000 CAPSULE CUTTER?

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

What is the FDA product code for FRIGITRONICS ACC-1000 CAPSULE CUTTER?

The FDA product code for FRIGITRONICS ACC-1000 CAPSULE CUTTER is HQC.

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Other records listing Frigitronics of Connecticut, 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.

K891282MIC-100 WITH CRYOPROBESK853308KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000K834577I/A PROBE LINESK840536CRYO SURG 5900K834437KEATES IRRIGATION/ASPIRATION/VITREOUSK822599KEATES I/A SYSTEM FRIGITRONICS 4000

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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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