Atlas FDA

MIC PEG TUBE

FDA 510(k) clearance K924065 · decided 1994-02-17

Clearance details

K-number
K924065
Device name
MIC PEG TUBE
Applicant
Medical Innovations Corp.
Decision
Unknown
Date received
1992-07-27
Decision date
1994-02-17
Days to decision
570 days
Clearance type
Traditional
Product code
KNT
Device class
2
Regulation number
876.5980
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Milpitas, CA, 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
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/ recall (Z-2341-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/ recall (Z-2342-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/ recall (Z-2343-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Cata recall (Z-2344-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Cata recall (Z-2345-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Cata recall (Z-2346-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors recall (Z-2347-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors recall (Z-2348-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors recall (Z-2349-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors recall (Z-2350-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors recall (Z-2351-2026)Avanos Medical, Inc.2026-06-05
Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors recall (Z-2352-2026)Avanos Medical, Inc.2026-06-05