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FDA 510(k)

10-K CASSETTE

K-Number: K942517 · 1994-07-25

ApplicantSurgin Surgical Instrumentation, Inc.
Decision Date1994-07-25
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

10-K CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Surgin Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1994-07-25 under 510(k) number K942517. 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 10-K CASSETTE?

10-K CASSETTE is a medical device that received FDA 510(k) clearance on 1994-07-25. The listed applicant is Surgin Surgical Instrumentation, Inc.. The 510(k) number is K942517.

When did 10-K CASSETTE receive FDA 510(k) clearance?

10-K CASSETTE received FDA 510(k) clearance on 1994-07-25, under 510(k) number K942517.

Who is the listed applicant for 10-K CASSETTE?

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

What is the FDA product code for 10-K CASSETTE?

The FDA product code for 10-K CASSETTE is HQC.

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Other records listing Surgin Surgical Instrumentation, 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.

K082110DUAL SYRINGE HOLDERK033236PRIZM KERATOME BLADE, MODEL MK8512M2K033182PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BDK011195PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CBK994015ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508K980849SURGIN KIT

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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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