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FDA 510(k)

SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM

K-Number: K942495 · 1995-02-21

ApplicantAtos Medical AB
Decision Date1995-02-21
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM 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 1995-02-21 under 510(k) number K942495. 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 SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM?

SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Atos Medical AB. The 510(k) number is K942495.

When did SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM receive FDA 510(k) clearance?

SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM received FDA 510(k) clearance on 1995-02-21, under 510(k) number K942495.

Who is the listed applicant for SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM?

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 SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM?

The FDA product code for SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM 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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