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FDA 510(k)

PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

K-Number: K891109 · 1989-05-08

ApplicantConcept, Inc.
Decision Date1989-05-08
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1989-05-08 under 510(k) number K891109. 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 PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE?

PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1989-05-08. The listed applicant is Concept, Inc.. The 510(k) number is K891109.

When did PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE receive FDA 510(k) clearance?

PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE received FDA 510(k) clearance on 1989-05-08, under 510(k) number K891109.

Who is the listed applicant for PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE?

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

What is the FDA product code for PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE?

The FDA product code for PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE is KNT.

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Other records listing Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K881954CONCEPT POWER SYSTEM

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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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