Atlas FDA

REPLACEMENT GASTROSTOMY TUBE

FDA 510(k) clearance K861323 · decided 1986-12-16

Clearance details

K-number
K861323
Device name
REPLACEMENT GASTROSTOMY TUBE
Applicant
Microvasive
Decision
Substantially Equivalent
Date received
1986-04-08
Decision date
1986-12-16
Days to decision
252 days
Clearance type
Traditional
Product code
KNT
Device class
2
Regulation number
876.5980
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Milford, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) (K253514)C.R. Bard, Inc.2026-07-10
XNY Disposable Gastric Calibration Tube (K250389)Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd2025-04-10
Flexi-Seal AIR (with ENFit Connector) (K243228)Convatec2025-03-28
hygh-tec Drainage II (K242336)Amb Medtec2025-01-17
ZZIREN™ 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) (K242901)Tools For Surgery, LLC2025-01-10
Entarik NI Feeding Tube System (K241169)Gravitas Medical, Inc.2024-11-22
CORGRIP* SR NG/NI Tube Retention System (K241185)Avanos Medical, Inc.2024-10-25
CORTRAK* 2 Enteral Access System (20-0950) (K240965)Avanos Medical, Inc.2024-06-06
Stylus (K233591)Degania Silicone , Ltd.2024-05-31
ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) (K241039)Reshape Lifesciences2024-05-16
ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (K234033)Boehringer Laboratories, LLC2024-05-06
Enteral Feeding Sets (K240039)Hangzhou Primecare Medical Co., Ltd.2024-04-17

Recalls involving this device

RecordFirmDate
Ross 14 FR Gastrostomy Tube, Item #152. recall (Z-0185-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 16 FR Gastrostomy Tube, Item #153. recall (Z-0186-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 18 FR Gastrostomy Tube, Item #154. recall (Z-0187-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 20 FR Gastrostomy Tube, Item #155. recall (Z-0188-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 22 FR Gastrostomy Tube, Item #156. recall (Z-0189-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 24 FR Gastrostomy Tube, Item #159. recall (Z-0190-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 26 FR Gastrostomy Tube, Item #50158. recall (Z-0191-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 16 FR Easy-Feed Gastrostomy Tube, Item #50112. recall (Z-0192-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 18 FR Easy-Feed Gastrostomy Tube, Item #50114. recall (Z-0193-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 20 FR Easy-Feed Gastrostomy Tube, Item #50116. recall (Z-0194-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 22 FR Easy-Feed Gastrostomy Tube, Item #50118. recall (Z-0195-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 14 FR Magna-Port Gastrostomy Tube, Item #51358. recall (Z-0196-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 16 FR Magna-Port Gastrostomy Tube, Item #51360. recall (Z-0197-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 18 FR Magna-Port Gastrostomy Tube, Item #51362. recall (Z-0198-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 20 FR Magna-Port Gastrostomy Tube, Item #51364. recall (Z-0199-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 22 FR Magna-Port Gastrostomy Tube, Item #51366. recall (Z-0200-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 24 FR Magna-Port Gastrostomy Tube, Item #54738. recall (Z-0201-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 28 FR Magna-Port Gastrostomy Tube, Item #54736. recall (Z-0202-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 18 FR Introducer Gastrostomy Kit with Brown Mueller T-Fastener Set, Item #50190. recall (Z-0203-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 22 FR Versa-PEG Gastrostomy Kit, Item #50520. recall (Z-0204-04)Ross Products Division, Abbott Laboratories2004-07-20
Ross 18 FR Lap G Laparoscopic Gastrostomy Kit with Brown Mueller T-Fastener Set, Item #511 recall (Z-0205-04)Ross Products Division, Abbott Laboratories2004-07-20