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FDA 510(k)

STORZ ASPIRATION MACHINE SAM 5000

K-Number: K843644 · 1984-11-16

ApplicantStorz Instrument Co.
Decision Date1984-11-16
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STORZ ASPIRATION MACHINE SAM 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Storz Instrument Co.. It received FDA 510(k) clearance on 1984-11-16 under 510(k) number K843644. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STORZ ASPIRATION MACHINE SAM 5000?

STORZ ASPIRATION MACHINE SAM 5000 is a medical device that received FDA 510(k) clearance on 1984-11-16. The listed applicant is Storz Instrument Co.. The 510(k) number is K843644.

When did STORZ ASPIRATION MACHINE SAM 5000 receive FDA 510(k) clearance?

STORZ ASPIRATION MACHINE SAM 5000 received FDA 510(k) clearance on 1984-11-16, under 510(k) number K843644.

Who is the listed applicant for STORZ ASPIRATION MACHINE SAM 5000?

The FDA 510(k) record lists Storz Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STORZ ASPIRATION MACHINE SAM 5000?

The FDA product code for STORZ ASPIRATION MACHINE SAM 5000 is BTA.

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Other records listing Storz Instrument Co. 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.

K980100STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACKK980488STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEMK972664STORZ MILLENNIUM VISCOUS FLUID SYSTEMK971439STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLESK964743STORZ E8010 ERGOTEC/PREMIERE ADAPTORK960024STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH

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Related Devices (Code: BTA)

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.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

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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