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FDA 510(k)

SURGICAL ASPIRATOR

K-Number: K850946 · 1985-09-16

ApplicantMedicalex
Decision Date1985-09-16
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

SURGICAL ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medicalex. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K850946. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SURGICAL ASPIRATOR?

SURGICAL ASPIRATOR is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Medicalex. The 510(k) number is K850946.

When did SURGICAL ASPIRATOR receive FDA 510(k) clearance?

SURGICAL ASPIRATOR received FDA 510(k) clearance on 1985-09-16, under 510(k) number K850946.

Who is the listed applicant for SURGICAL ASPIRATOR?

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

What is the FDA product code for SURGICAL ASPIRATOR?

The FDA product code for SURGICAL ASPIRATOR is BTA.

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 Medicalex 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.

K851349LERE NAIL & PLATE COMBIN. ONE PIECE FORGEDK833377MEDICALEXK831728MEDICALEX

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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