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FDA 510(k)

DISPOSABLE SILICONE EPISTAXIS CATHETER

K-Number: K973656 · 1997-11-18

ApplicantSpecialty Surgical Products, Inc.
Decision Date1997-11-18
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SILICONE EPISTAXIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Surgical Products, Inc.. It received FDA 510(k) clearance on 1997-11-18 under 510(k) number K973656. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE SILICONE EPISTAXIS CATHETER?

DISPOSABLE SILICONE EPISTAXIS CATHETER is a medical device that received FDA 510(k) clearance on 1997-11-18. The listed applicant is Specialty Surgical Products, Inc.. The 510(k) number is K973656.

When did DISPOSABLE SILICONE EPISTAXIS CATHETER receive FDA 510(k) clearance?

DISPOSABLE SILICONE EPISTAXIS CATHETER received FDA 510(k) clearance on 1997-11-18, under 510(k) number K973656.

Who is the listed applicant for DISPOSABLE SILICONE EPISTAXIS CATHETER?

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

What is the FDA product code for DISPOSABLE SILICONE EPISTAXIS CATHETER?

The FDA product code for DISPOSABLE SILICONE EPISTAXIS CATHETER is EMX.

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Other records listing Specialty Surgical Products, Inc. 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.

K984106MAMMARY SIZER, MAMMARY PROTHESIS SIZERK983015VIRILIS PENILE PROSTHESISK982258MAMMARY SIZERK982065STERILE SILICONE EXTERNAL WOUND COVERK982067MAGNETIC PORT SILICONE TISSUE EXPANDERK974653SILICONE ELASTOMER SHEETING

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Related Devices (Code: EMX)

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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, 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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