FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DECOMPRESSION TUBES
K Number: K920894
·
Decision Apr 28, 1992
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
23
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DECOMPRESSION TUBES
- K Number
- K920894
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Applied Medical Technologies
- Date Received
- February 21, 1992
- Decision Date
- April 28, 1992
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNT), ordered by most recent decision date.
XNY Disposable Gastric Calibration Tube
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flexi-Seal AIR (with ENFit Connector)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
hygh-tec Drainage II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Entarik NI Feeding Tube System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORGRIP* SR NG/NI Tube Retention System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Applied Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K971434 | A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE | Aug 17, 1998 | Substantially Equivalent |
| K972478 | PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES | Feb 9, 1998 | Substantially Equivalent |
| K973893 | AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE | Dec 19, 1997 | Substantially Equivalent |
| K971757 | LOW PROFILE FEEDING SET ACCESSORY | Nov 7, 1997 | Substantially Equivalent |
| K971758 | CAUTERIZATION SMOKE EVACUATOR | Jul 21, 1997 | Substantially Equivalent |
| K961345 | DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE | Sep 17, 1996 | Substantially Equivalent |
| K960232 | ENDOSCOPIC ACCESS DEVICE | Mar 21, 1996 | Substantially Equivalent |
| K945618 | GASTROINTESTINAL TUBES & ACCESSORIES | Oct 12, 1995 | Substantially Equivalent |
| K946140 | PRG BUTTON | Aug 28, 1995 | Substantially Equivalent |
| K923488 | GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY | Jul 20, 1995 | Substantially Equivalent |