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FDA 510(k)

COOK ASPIRATION/IRRIGATION UNIT

K-Number: K944818 · 1994-11-08

ApplicantCook Urological, Inc.
Decision Date1994-11-08
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOK ASPIRATION/IRRIGATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1994-11-08 under 510(k) number K944818. 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 COOK ASPIRATION/IRRIGATION UNIT?

COOK ASPIRATION/IRRIGATION UNIT is a medical device that received FDA 510(k) clearance on 1994-11-08. The listed applicant is Cook Urological, Inc.. The 510(k) number is K944818.

When did COOK ASPIRATION/IRRIGATION UNIT receive FDA 510(k) clearance?

COOK ASPIRATION/IRRIGATION UNIT received FDA 510(k) clearance on 1994-11-08, under 510(k) number K944818.

Who is the listed applicant for COOK ASPIRATION/IRRIGATION UNIT?

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

What is the FDA product code for COOK ASPIRATION/IRRIGATION UNIT?

The FDA product code for COOK ASPIRATION/IRRIGATION UNIT is BTA.

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Other records listing Cook Urological, Inc. as applicant

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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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