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FDA 510(k)

CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE

K-Number: K935512 · 1996-08-29

ApplicantCorpak Co.
Decision Date1996-08-29
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE is the device name listed in this FDA 510(k) record. The listed applicant is Corpak Co.. It received FDA 510(k) clearance on 1996-08-29 under 510(k) number K935512. 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 CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE?

CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE is a medical device that received FDA 510(k) clearance on 1996-08-29. The listed applicant is Corpak Co.. The 510(k) number is K935512.

When did CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE receive FDA 510(k) clearance?

CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE received FDA 510(k) clearance on 1996-08-29, under 510(k) number K935512.

Who is the listed applicant for CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE?

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

What is the FDA product code for CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE?

The FDA product code for CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE is KNT.

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Other records listing Corpak Co. as applicant

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K931921CORPAK GASTROSTOMY TUBEK932847CORPAK ENTERAL PUMPK902949CORPAK GRASPING FORCEPSK901501CORPAK GASTROSTOMY TUBEK882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBEK853253CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI

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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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