510(k) K841036
- Device
- RECTAL BALLOON CATHETERS
- Applicant
- INMED CORP.
- 510(k) number
- K841036
- Product code
- KNT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-04-13
- Date received
- 1984-03-12
- Regulation
- 876.5980
- Classification name
- Tubes, Gastrointestinal (and Accessories)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1649518
- 3012441529
- 9616088
- 3003627840
- 3006131984
- 2431014
- 3006161756
- 3011987967
- 3010400865
- 3009211636
- 3011270181
- 3009291251
- 2133810
- 3005012805
- 2011171
- 2183744
- 1000121056
- 3005060859
- 3008311916
- 3035642068
- 1480288
- 3005099803
- 1024404
- 1221765
- 3010331226
- 3018167761
- 3042225166
- 3013557562
- 8030107
- 1054241
- 3002808467
- 2528981
- 3004904811
- 2024024
- 3009558349
- 3030446844
- 1018233
- 1214422
- 9611590
- 3015173212
- 3010041511
- 3016616327
- 1526012
- 3005609751
- 3014656749
- 3004122598
- 1423537
- 3008570882
- 3041276591
- 9710641
- 3004550973
- 9680143
- 3006271008
- 3012481535
- 2183673
- 3016171914
- 1526854
- 1718873
- 3031190571
- 3006673317
- 3022964615
- 1293141
- 1055236
- 3017081712
- 1928237
- 1058397
- 3006538822
- 3001124136
- 1417592
- 2245270
- 3011137372
- 3011237770
- 1213809
- 2182291
- 3031289255
- 3013234390
- 3004111573
- 3030447506
- 1043214
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KNT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262038 | danumed StomaMeter | Danumed Medizintechnik GmbH | 2026-09-30 |
| K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | 2026-08-14 |
| K253514 | Minnesota 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. | 2026-07-10 |
| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025-04-10 |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | 2025-03-28 |
| K242336 | hygh-tec Drainage II | Amb Medtec | 2025-01-17 |
| K242901 | 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) | Tools For Surgery, LLC | 2025-01-10 |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024-11-22 |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. | 2024-10-25 |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. | 2024-06-06 |
| K233591 | Stylus | Degania Silicone , Ltd. | 2024-05-31 |
| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | Reshape Lifesciences | 2024-05-16 |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | 2024-05-06 |
| K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. | 2024-04-17 |
| K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | Endolumik | 2024-02-08 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases