AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
FDA 510(k) clearance K973893 · decided 1997-12-19
Clearance details
- K-number
- K973893
- Device name
- AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
- Applicant
- Applied Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1997-10-14
- Decision date
- 1997-12-19
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cleveland, OH, 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.
| Record | Firm | Date |
|---|
| 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.,Ltd | 2025-04-10 |
| Flexi-Seal AIR (with ENFit Connector) (K243228) | Convatec | 2025-03-28 |
| hygh-tec Drainage II (K242336) | Amb Medtec | 2025-01-17 |
| 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, LLC | 2025-01-10 |
| 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 Lifesciences | 2024-05-16 |
| ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (K234033) | Boehringer Laboratories, LLC | 2024-05-06 |
| Enteral Feeding Sets (K240039) | Hangzhou Primecare Medical Co., Ltd. | 2024-04-17 |
Recalls involving this device
No recalls on record reference this clearance.