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FDA 510(k)

RECTAL BALLOON CATHETERS

K-Number: K841036 · 1984-04-13

ApplicantInmed Corp.
Decision Date1984-04-13
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RECTAL BALLOON CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Corp.. It received FDA 510(k) clearance on 1984-04-13 under 510(k) number K841036. 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 RECTAL BALLOON CATHETERS?

RECTAL BALLOON CATHETERS is a medical device that received FDA 510(k) clearance on 1984-04-13. The listed applicant is Inmed Corp.. The 510(k) number is K841036.

When did RECTAL BALLOON CATHETERS receive FDA 510(k) clearance?

RECTAL BALLOON CATHETERS received FDA 510(k) clearance on 1984-04-13, under 510(k) number K841036.

Who is the listed applicant for RECTAL BALLOON CATHETERS?

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

What is the FDA product code for RECTAL BALLOON CATHETERS?

The FDA product code for RECTAL BALLOON CATHETERS is KNT.

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Other records listing Inmed Corp. 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.

K862672ESOPHAGEAL STETHOSCOPE WITH THERMISTORK853162STERILE NASOPHARYNGEAL AIRWAYK850335URETEROSCOPY CATHETERK850152PRECONNECTED URETHRAL CATHETER TRAYK850248DISPOSABLE GUEDEL AIRWAYK844801ULTRA EXTERNAL CATHETER

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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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