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FDA 510(k)

SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS

K-Number: K922145 · 1993-01-21

ApplicantAtos Medical AB
Decision Date1993-01-21
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS is the device name listed in this FDA 510(k) record. The listed applicant is Atos Medical AB. It received FDA 510(k) clearance on 1993-01-21 under 510(k) number K922145. The device is classified under product code KAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS?

SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS is a medical device that received FDA 510(k) clearance on 1993-01-21. The listed applicant is Atos Medical AB. The 510(k) number is K922145.

When did SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS receive FDA 510(k) clearance?

SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS received FDA 510(k) clearance on 1993-01-21, under 510(k) number K922145.

Who is the listed applicant for SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS?

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

What is the FDA product code for SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS?

The FDA product code for SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS is KAM.

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Other records listing Atos Medical AB 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.

K151404ProTrach DualcareK131947PROVOX VEGA PUNCTURE SETK092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)K090455PROVOX VEGA, MODEL 8130-8135K072582PROVOX MICRON HMEK043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134

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Related Devices (Code: KAM)

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.

K110687RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)Acclarent, Inc.K093594MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K083574RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K072891SINUS SPACERAcclarent, Inc.K073041RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETERAcclarent, Inc.K071845RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AAcclarent, Inc.

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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