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FDA 510(k)

SCLEROTHERAPY INJECTION CATHETER

K-Number: K860991 · 1986-05-02

ApplicantEndovations
Decision Date1986-05-02
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SCLEROTHERAPY INJECTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Endovations. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K860991. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCLEROTHERAPY INJECTION CATHETER?

SCLEROTHERAPY INJECTION CATHETER is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Endovations. The 510(k) number is K860991.

When did SCLEROTHERAPY INJECTION CATHETER receive FDA 510(k) clearance?

SCLEROTHERAPY INJECTION CATHETER received FDA 510(k) clearance on 1986-05-02, under 510(k) number K860991.

Who is the listed applicant for SCLEROTHERAPY INJECTION CATHETER?

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

What is the FDA product code for SCLEROTHERAPY INJECTION CATHETER?

The FDA product code for SCLEROTHERAPY INJECTION CATHETER is KNT.

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Other records listing Endovations 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.

K955413ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETERK942110INJECT-SNAREK934315ENDOVATIONS(R) .035 PRE-CUT PAPILLATOMEK9138412 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATHK9138705MM MICROSCISSORSK911155OVAL CUP BIOPSY FORCEP

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Related Devices (Code: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

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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